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High Fashion Futurism Defined The Hair At The SS22 Shows – elle.com
Posted: October 7, 2021 at 3:24 pm
Every season, as fashion month rolls around, we're tempted to try a hair trend that previously we would have scoffed at (now we just nod in appreciation and run to our laptops to google at-home hacks). Razor sharp space buns with pointed edges? Yes please. Match your hair colour to the exact shade of your outfit? Sure. In fact, why on earth didnt we think of it before?
No more 'I just woke up like this' undone hair, for SS22 it's all about showing off that we've spent hours straightening our hair to poker straight noughties extremes. In fact, whether it's straightened, styled, coloured or slicked back, the future is totally intentional. A little bit Y2K, a little bit 'Year 3000', a lot high fashion futurism. Whatever you go for make it extreme and most definitely not landing in the middle.
Maybe its the beginning of a new cultural mood as the next Matrix movie gears up to hit cinema screens, or maybe it's because literally everyone we speak to is watching the dystopian world of Squid Game and we've got change on the mind, but the hair at SS22 saw the future for hair and it was a bold new era.
From the nose-grazing pastel wigs at Loewe, to the searing purple and green hues seen at Valentino, both conjured up by hair stylist Guido Palau, multi-coloured hair was back in a big way. Even the throwback references had futurism at their core, with nods to Leeloo in Fifth Elements hyper copper bob, Scarlett Johansens iconic bubblegum pink wig in Lost In Translation, Natalie Portmans flamingo fringe in Closer and dare we say it, even a touch of Miley Cyruss lilac bob as Ashley O in Black Mirror all hitting the runway.
Over at Rick Owens, hair stylist Duffy stuck strands of hair onto models' faces using gel for an otherworldly high shine finish. In London, Richard Quinn employed the legendary skills of Sam McKnight to create a chunky subdivided slicked back updo in a new twist on the go-to fashion week wet look that wouldn't look out of place in Star Trek. Think the opposite of low-key mid-pandemic hair. Now, hyper polished, high maintenance and high concept hair has landed.
Even space buns got a less literal update at fashion set favourite Nensi Dojaka courtesy of hair stylist Syd Hayes. We added this sort of futuristic element with razor edges, Hayes told ELLE. 'It gives the face a sharp look, pulling it back at the edges like fake Botox, referencing an almost alien-esque glam sophistication. Were getting big Sex Educations Lily and her space buns but make it high fashion energy.
To achieve the look, Hayes used a gel through the whole of the ponytail, then we put the ponytail really high at the top of the head at the point where your skull goes flat. Next, I split it into two and twisted it in different directions, so that when you wrap the two strands around each other it looks a bit like a chain. Finally, I left the ends out of the fastened bun and sprayed them with hairspray before straightening to achieve the razor-sharp edges.
Studio Line Invisi'Hold Gel Normal
9000 Cordless Straightener
Flyaway With Me Kit
19.00
Can we pull it off? Unclear. But will we try? Almost certainly.
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This Scary-Looking Robot Can Walk and Fly – Futurism
Posted: at 3:24 pm
It can even skateboard and slackline.Get It Off Me
Researchers at Caltech have opened the doors to hell and allowed a creepy robot that can walk on two spindly feet and even fly to enter our world.
The terrifying biped, called LEONARD (LEgs ONboARD drone), or LEO for short, is basicically the bottom half of a humanoid robot strapped to a flying drone.
The researchers goal wasnt to come up with the next mass-marketable invention, but to test new ways of locomotion for robots meant to complete dangerous jobs and explore hard-to-reach places.
Did we mention it can skateboard and slackline as well?
The team goes as far to suggest that their creepy invention could carry equipment on the surface of other worlds, including Mars or Saturns moon Titan.
We drew inspiration from nature, Soon-Jo Chung, corresponding author of the paper published this week in the journal Science Robotics, said in a statement.
A complex yet intriguing behavior happens as birds move between walking and flying, Chung added. We wanted to understand and learn from that.
One major challenge for the team was to conserve enough energy to allow the bot to fly while also covering some distance on the ground.
Based on the types of obstacles it needs to traverse, LEO can choose to use either walking or flying, or blend the two as needed, Patrick Spieler, co-lead author, said in the statement.
In addition, LEO is capable of performing unusual locomotion maneuvers that even in humans require a mastery of balance, like walking on a slackline and skateboarding, he added.
Next, the team is hoping to decrease LEOs weight and increase the thrust of its propellers to allow it to cover even more ground.
Its exactly what we needed: an apocalyptic murder drone that can not only fly but also run to catch up with us.
READ MORE: LEONARDO, the Bipedal Robot, Can Ride a Skateboard and Walk a Slackline [Caltech]
More on robots: People in Singapore Furious About Robot Cops That Lecture People on Social Distancing
Care about supporting clean energy adoption? Find out how much money (and planet!) you could save by switching to solar power at UnderstandSolar.com. By signing up through this link, Futurism.com may receive a small commission.
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Bishkek’s multi-faith wedding palace is a futuristic, grandiose atheist temple | Concrete Ideas – The Calvert Journal
Posted: at 3:24 pm
In the Soviet Union, places of worship were largely shut down, in line with communist ideologys denunciation of religion as the opium of the masses. However, Soviet authorities did not want to leave citizens without lavish temples to celebrate rites of passage or family milestones. Instead, they built state-run wedding palaces that would offer grandeur while avoiding the pesky burden of spirituality.
One of these pompous buildings was Bishkeks Wedding Palace, a pointy glass-and-marble venue built in the northeast of Kyrgyzstans capital in 1987. Conceived by architects A. Logunov and A. Klishevich as a non-denominational, state-run house of worship, they wanted its design to combine the futuristic, monolithic trends of the era, with elements of traditional religious venues. By mimicking the grandeur of cathedrals and mosques, they hoped the building would evoke the same sense of reverence and spirituality as traditional temples.
The building stands at one end of a circular square, in front of a water fountain comprised of colourful mosaics. Its facade is almost entirely made of stained glass windows, only interrupted by marble columns. Its irregular roof, marked by spiky towers on the four corners, makes the palace look like a futuristic castle, where an opulent staircase leads to the main door. Inside, marble-heavy interiors, vaulted painted ceilings, and colourful stained glass windows create a grandiose, cathedral-like atmosphere. In the centre of the main room, a maroon carpet leads up a flight of stairs into a ceremonial chamber, through a glass painted window surrounded by circular mouldings. Through the door of the main chamber, a celestial stream of light inundates the venue.
While the building is now in need of repair due to the lack of state funds, many Kyrgyzstani couples still choose to get married at the wedding palace in Bishkek. Over the years, a bazaar-like setup has developed around the venue to cater for wedding-goers demands, from gifts to outfits and picture props. Across the street, colourful flower stands fight for the attention of ceremony guests. A large store sells silk wedding dresses, party attire, and shiny tuxedos. Nearby, doves are kept in cages, and, for a small price, they can be released by happy couples (before happily returning back to their perches). On a nearby road, a limousine rental company allows couples to choose from a fleet of luxury cars, to leave the lavish wedding palace in an equally extravagant manner.
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Bishkek's multi-faith wedding palace is a futuristic, grandiose atheist temple | Concrete Ideas - The Calvert Journal
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Imiquimod-induced psoriasis-like skin inflammation in mice …
Posted: October 5, 2021 at 4:45 am
Topical application of imiquimod (IMQ), a TLR7/8 ligand and potent immune activator, can induce and exacerbate psoriasis, a chronic inflammatory skin disorder. Recently, a crucial role was proposed for the IL-23/IL-17 axis in psoriasis. We hypothesized that IMQ-induced dermatitis in mice can serve as a model for the analysis of pathogenic mechanisms in psoriasis-like dermatitis and assessed its IL-23/IL-17 axis dependency. Daily application of IMQ on mouse back skin induced inflamed scaly skin lesions resembling plaque type psoriasis. These lesions showed increased epidermal proliferation, abnormal differentiation, epidermal accumulation of neutrophils in microabcesses, neoangiogenesis, and infiltrates consisting of CD4(+) T cells, CD11c(+) dendritic cells, and plasmacytoid dendritic cells. IMQ induced epidermal expression of IL-23, IL-17A, and IL-17F, as well as an increase in splenic Th17 cells. IMQ-induced dermatitis was partially dependent on the presence of T cells, whereas disease development was almost completely blocked in mice deficient for IL-23 or the IL-17 receptor, demonstrating a pivotal role of the IL-23/IL-17 axis. In conclusion, the sole application of the innate TLR7/8 ligand IMQ rapidly induces a dermatitis closely resembling human psoriasis, critically dependent on the IL-23/IL-17 axis. This rapid and convenient model allows further elucidation of pathogenic mechanisms and evaluation of new therapies in psoriasis.
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Psoriasis Diet: What It Is, Best Foods to Eat and Food You Should Avoid – GoodHousekeeping.com
Posted: at 4:45 am
Dusan StankovicGetty Images
If youre one of the roughly 7.5 million Americans living with psoriasis, you know it isnt exactly fun. While you may go for years without symptoms, when you have a psoriasis flare-up, it can be everything from uncomfortable to downright distressing. And part of what makes it such a difficult condition to deal with is because you never know when a flare-up might occur and what could cause it. One biggie thats thought to cause flare-ups is food.
Certain types of foods appear to trigger or worsen psoriasis symptoms, and others may actually help tame signs of psoriasis, but everyone is different and foods that trigger flare-ups for some may not affect others with psoriasis, so pay attention to what seems to personally affect you, says Annie Gonzalez, M.D., F.A.A.D, a board-certified dermatologist at Riverchase Dermatology in Miami, Florida.
To help, we rounded up the best foods to eat if you have psoriasis and ones you should try to avoid, if you can.
Psoriasis is a skin disease with an unclear cause whats known is that it happens when the immune system goes into overdrive, triggering inflammation and inflammatory skin symptoms due to that overactivity that speeds up skin cell growth. The most common type of psoriasis (80%-90% of people with psoriasis have this kind) is called plaque psoriasis, characterized by patches of thick, raised skin that may itch and be red or partially covered in silvery-white scales; these patches can develop anywhere but tend to appear on the elbows, knees, lower back and scalp. Other ways a psoriasis flare-up may manifest is as tiny, salmon-to-pink colored bumps; smooth, raw-looking red patches around skin creases like the armpits; red, swollen skin dotted with pus-filled bumps; and as nail issues like tiny dents, rough crumbling nails, discoloration or lifting of the nail.
Weather, stress, infections (such as strep throat), smoking or secondhand smoke and certain medications, like those to treat high blood pressure are some common psoriasis flare triggers. Food is also thought to play a role in prompting of psoriasis flares. Specifically, inflammatory foods (a.k.a. foods that cause inflammation in the body) are thought to be common culprits, but more research in this area needs to be done. My advice is, if you notice your skin gets worse after eating certain foods, avoid and stop eating them to see what happens, says Dr. Gonzalez.
In general, eat a well-balanced diet thats high in fruits and vegetables and healthy fats this mix ensures youre consuming an array of nutrients and antioxidants that help prevent and reduce inflammation that could trigger a psoriasis flare-up.
alice dias didszoleitGetty Images
Fruits and veggies may reduce inflammation because theyre high in antioxidants and vitamins, which have been also been related to lower levels of oxidative stress and inflammation, says Gonzalez. Aromatics like onions and garlic are also smart to incorporate; they contain quercetin, an anti-inflammatory antioxidant.
Load up on:
Heart-healthy fats and omega-3 fatty acids have anti-inflammatory properties that can help decrease inflammation to alleviate or prevent symptoms.
Load up on:
Many of these flavor enhancers are also thought to play a role in taming inflammation.
Load up on:
Foods to avoid if you have psoriasis:
Remember: Not every food on this list will definitely trigger a psoriasis flare-up, but if you do notice that your diet is affecting your skin, these inflammatory foods might be to blame, and cutting back or eliminating may help. Foods that have been known to trigger psoriasis include eggs, red and processed meat, canned produce, and packaged or processed foods, Gonzalez says.
These types of proteins tend to be high in saturated fat, an inflammation raiser and processed meats often contain preservatives, additives, and other flavor enhancers that may have a similar affect.
Avoid or limit:
These types of products often contain various inflammation triggers, such as added sugar, trans fat, preservatives, sodium and flavorings.
Avoid or limit:
Some research suggests that people with psoriasis may also be sensitive to gluten, a protein found in wheat, barley, and rye, possibly due to similar genetic and other inflammatory markers that affect people with Celiac disease.
Avoid or limit:
Everyone is different and different bodies will react differently to certain foods. Try jotting down which foods seem to impact your skin, so you can keep track and have that information on hand to consult with your doctor about your diet.
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Novel Topical Found Effective for Psoriasis in 52-Week Study – Medscape
Posted: at 4:45 am
Treatment with tapinarof 1%, a nonsteroidal topical cream in clinical development, was associated with durable control of plaque psoriasis in a 52-week phase 3 trial presented as a latebreaker at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.
The drug has several unique features with meaningful clinical differences from other topical psoriasis therapies, according to Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health System, Detroit, Michigan.
"The currently available nonsteroidal topical therapies are typically associated with significant irritation. We did not see that with tapinarof," said Gold. This is one of several reasons she believes this drug will be a valuable addition if it receives regulatory approval.
Tapinarof is a small-molecule aryl hydrocarbon receptor (AhR) modulating agent. AhR is widely expressed in immune cells, including macrophages, mast cells, and antigen-presenting cells. It is believed that modulation of AhR signaling by tapinarof reverses immune dysregulation that is involved in the formation of psoriatic lesions.
The newly presented PSOARING 3 data with tapinarof 1% build on the data from the 12-week PSOARING 1 and PSOARING 2 trials, which were released in August 2020 but have yet to be published.
The primary endpoint in both of the 12-week trials, each of which enrolled about 500 patients with plaque psoriasis, was a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear). Relative to a placebo response rate of about 6% in both trials, the proportion of patients who achieved scores of 0/1 with tapinarof 1% was 35.4% and 40.2% in the PSOARING 1 and PSOARING 2 trials, respectively (P < .0001 vs placebo in both studies).
For the key secondary endpoint of 75% improvement in the Psoriasis Area and Severity Index (PASI75), the relative advantage for tapinarof over placebo was similar. The results were highly statistically significant (P < .0001) in both of the 12-week trials.
More than 90% of the patients who participated in PSOARING 1 and PSOARING 2 and were eligible for the open-label PSOARING 3 extension trial, according to Gold.
For the 79 patients with a score of 0 at the time of enrollment, tapinarof 1% was reapplied only if the PGA score reached 2 during the course of the study. For the 680 patients who entered with a PGA score of 1, once-daily applications of tapinarof 1% cream were maintained until a PGA score of 0 was achieved.
In the outcome analysis, response was defined as the proportion of patients with an initial PGA score of 2 who achieved PGA 0. A remittive effect was defined as duration of a PGA score of 0 or 1 while off therapy after achieving a PGA score of 0. Durability of response was defined as the proportion of patients who achieved a PGA sore of 0 or 1 at least once during the study while on therapy. This last outcome provided a test of tachyphylaxis.
"Overall, 40.9% of patients achieved complete disease clearance at least once during the trial, and 58.2% who entered the study with a PGA score of 2 or higher achieved a PGA score of 0 or 1," Gold reported.
For the 79 patients who entered PSOARING 3 with a PGA score of 0 and were off treatment, the median duration of a remittive effect was 115 days. For the patients who entered the trial with a higher PGA score but who achieved a score of 0 during the study (312 patients), the mean remittive effect after discontinuing therapy was 130 days.
There was no evidence of tachyphylaxis. Rather, "there was no loss of effect despite intermittent therapy observed over the course of the trial," Gold reported.
The most common treatment-emergent adverse events in PSOARING 3, as in the previous PSOARING studies, were folliculitis, which was observed in 24.0% of patients; contact dermatitis, which occurred in 5.9% of patients; and headache, which was reported in 2%. Rates of study drug discontinuations for folliculitis and contact dermatitis were 1.2% and 1.4%, respectively. Headache did not lead to any study discontinuations.
Calling tapinarof a "first-in-class nonsteroidal," Gold suggested that this is likely to be a useful adjunctive therapy for psoriasis control. It avoids the adverse events associated with long-term topical steroid use, and its tolerability might be particularly attractive for use in sensitive areas.
"This is likely to be very useful in patients who are looking for a topical therapy for skin folds or the face, where there is a need for well-tolerated topical treatments," Gold said.
There are a lot of reasons to be positive about a new, well-tolerated topical agent for psoriasis, particularly as an alternative to topical steroids, agreed Adam Friedman, MD, director of translational research and professor and chair of the Department of Dermatology at George Washington School of Medicine and Health Sciences, Washington, DC. He considers the data with tapinarof promising in general, but he also likes any new, effective topical psoriasis therapy.
"Patients and physicians are always hungry for new options, especially psoriasis patients, given many have 'been there and done that' with topical steroids," Friedman said.
"Topical steroids are not irritating, but long-term use beyond recommended dosing can lead to skin thinning, lightening, tachyphylaxis, and, if really abused, HPA [hypothalamic-pituitary-adrenal]axis suppression and adrenal insufficiency," he observed.
A topical therapy with a durable effect is particularly intriguing.
"The other issue with topical steroids is that psoriatic plaques return rather easily after stopping. The data I have seen with tapinarof show more sustainability after cessation, owing to its mechanism of action," Friedman said. Rather than its potential for application to sensitive areas, such as the face, the durability "to me is more interesting," he said.
He suspects that, owing to "the incurable steroid phobia that haunts many of our patients," an effective nonsteroidal topical option is also likely to lead to better compliance with topical treatment over time.
"A well-tolerated nonsteroidal topical drug will probably find an important place in the future management of chronic inflammatory diseases," Marius-Anton Ionescu, MD, PhD, a dermatologist at the Hpital Saint Louis, Paris, France, said in an interview. He referred to the positive effects of treatment with tapinarof in clinical trials in adults with atopic dermatitis, in addition to psoriasis.
Tapinarof 1% is also being investigated in a phase 3 study involving patients with moderate to severe atopic dermatitis. In that study, patients are as young as age 2 years. The drug is under review at the US Food and Drug Administration for the plaque psoriasis indication in adults.
Gold has financial relationships with Arcutis, Amgen, Bristol-Myers Squibb, Eli Lilly, Leo Pharma Ortho Dermatologic, UCB, and Dermavant Sciences, which is developing tapinarof and is provided funding for the PSOARING 3 trial. Friedman reports financial relationships with Amgen, Biogen, Encore, Galderma, GlaxoSmithKline, IntraDerm, Johnson & Johnson, Nerium, Novartis, Oculus, Onset, Pfizer, Sanova, and Valeant Pharmaceuticals. Ionescu has been a speaker or investigator (honoraria) for Celgene, Novartis, Lilly, and Uriage Cosmetics.
European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting: Abstract 2860. Presented September 30, 2021.
Ted Bosworth is a medical journalist based in New York City.
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Individuals With Psoriasis Are Hesitant to Get Vaccinated for COVID-19 – Pharmacy Times
Posted: at 4:45 am
The main factors behind the vaccine hesitancy are the potential adverse effects post-vaccination and effect on their autoimmune conditions, as well as lack of trial data, an analysis shows.
Individuals with psoriasis are hesitant to get the COVID-19 vaccination, but there is no differential risk of respiratory tract infection (RTI) and serous infection (SI), the results of 2 new studies presented at the European Academy of Dermatology and Venereologys (EADV) 30th Congress show.
Our analysis reveals no differences in risk of respiratory tract infections between biologics, including the newer IL-17 and IL-23 inhibitors, in a prospective psoriasis patients cohort. In addition, our preliminary results suggest that biological treatments do not impact psoriasis patients susceptibility to COVID-19 infections, although this needs to be further investigated, Lara van der Schoot of the department of dermatology at Radboud University Medical Center in Nijmegen, Netherlands, said in a statement.
These findings provide key clinical value and will help to guide patient decisions with regard to psoriasis treatment options and choice, she said.
Results from the first study show that COVID-19 vaccine hesitancy was driven by safety concerns and worries about aggravation of the individuals underlying conditions, as well as a lack of trial data.
Additionally, investigators said that individuals had no information on the effect of the COVID-19 vaccine on biologic therapy in immunocompromised individuals.
Treatments for psoriasis are often associated with an increase in infections, so in the second study, investigators examined the effect of biological therapies on the risk for RTI and SI, including COVID-19.
Investigators found that there was no differential risk of RTI among included biologics adalimumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab, and no association with serious infections.
In the first unique study, investigators collected real-world data from social media to minimize limitations from traditional hospital surveys.
Investigators gathered 10,922 social media posts between January and March 2021. They included individuals in France, Germany, Spain, the United States, and the United Kingdom, using pre-defined words, which were narrowed down to 625 posts that were manually analyzed.
The second study included 714 individuals with psoriasis, with 1325 treatment episodes from the BioCAPTURE registry, 2224 with RTI and 63 with SI.
Just 1.3% of RITs were reported to be serious.
Reference
Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients. EurekAlert. News release. September 30, 2021. October 1, 2021. https://www.eurekalert.org/news-releases/929887
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Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis -…
Posted: at 4:45 am
WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.(Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.
Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments.
Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise, said Frank Watanabe, President and CEO of Arcutis. Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, patients, and partners, for helping us reach this important milestone.
Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population. The majority of patients develop plaques, or raised, red areas of skin covered with a silver or white layer of dead skin cells. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and areas where two skin areas may touch or rub together.
Topical treatments are the mainstay of therapy for the vast majority of psoriasis patients, particularly those with mild-to-moderate disease, as well as many moderate-to-severe patients who use topicals in combination with other treatments. However, existing topical treatments often force physicians and patients to make difficult trade-offs between tolerability and long-term use, requiring the use of multiple products or complicated treatment schedules. Roflumilast cream has been designed to address the challenges posed to dermatologists and patients by existing topical therapies and aims to simplify the overall management of plaque psoriasis.
Arcutis submission is supported by positive data from Arcutis pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition withRoflumilast for theManagement of plaque PsoriasIS One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy ofroflumilast cream 0.3%. Roflumilast met its primary endpoint and had an IGA Success rate of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.
About Roflumilast CreamRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.
About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions, with one NDA submission now under review with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The companys lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visitwww.arcutis.comor follow Arcutis on LinkedIn and Twitter.
Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and adolescents with plaque psoriasis, the potential to use roflumilast cream over a long period of time, or chronically, and the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com
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Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis -...
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MoonLake over the moon with $230M SPAC deal for llama antibodies to challenge Novartis’ Cosentyx – FierceBiotech
Posted: at 4:45 am
MoonLake Immunotherapeutics will soon have $230 million to bankroll trials ofan investigational drug that signaled it could outperformed Novartis' Cosentyx in a midstage study last year.
That financing is thanks to a blank-check tie-up the Swiss biotech inkedMonday with Helix Acquisition. The special purpose acquisition company, sponsored by Cormorant, will take MoonLake to Wall Street to fund multiple phase 2 studies of the tri-specific nanobody, dubbed sonelokimab.
MoonLake debuted with the drug in May after licensing it from Merck KGaA. The treatment's former owner took it through a phase 2b study in more than 300 patients with moderate to severe psoriasis and compared it to placebo and Novartis' Cosentyx.
The drug beat placebo on multiple measures after 12 weeks and was able to outperform Cosentyx but not enough to be statistically significant, Merck KGaA said last October. The treatment has shifted hands multiple times, with Merck KGaA originally snagging the license from Ablynx in 2013.
RELATED:MoonLake debuts with Cosentyx challenger from Merck KGaA
As a public company, MoonLake plans to take sonelokimab into midstage studies in patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS) or radiographic axial spondyloarthritis (RaxSpA) and hidradenitis suppurativa (HS).
MoonLake will attempt to go up against a drug that has already received the green light in multiple skin and joint diseases. Novartis' Cosentyx is already approved in moderate-to-severe plaque psoriasis, PsA, AS as well as nonradiographic axSpA and in June received the go-ahead to treat children and adolescents with plaque psoriasis. The drug is also in a phase 3 HS study.
MoonLake's treatment is derived from nanobodies, compared to Cosentyx, which is based on conventional antibodies. Nanobodies are found naturally in llamas and other camelids and need only a single variable to its domain to recognize its target.
RELATED:Lilly scraps IL-23 psoriasis program despite phase 3 success, focuses on IBD race against AbbVie, J&J
Nanobodies such as sonelokimab are an exciting emerging therapeutic modality and sonelokimab has been engineered to have properties that may underpin potential for differentiated clinical activity in deep tissue and joint settings where IL-17A and IL-17F biology is emerging as central to disease," said Andy Phillips, Helix's chief financial officer and a managing director at Cormorant, in a statement.
The deal is slated to close later this quarter or in early 2022. MoonLake will list on the Nasdaq under the symbol "MLTX."
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MoonLake over the moon with $230M SPAC deal for llama antibodies to challenge Novartis' Cosentyx - FierceBiotech
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Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients -…
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LUGANO, 30 September, 2021 Real-world data looking at biologic treatment and vaccine hesitancy in psoriasis patients is being presented today at EADVs 30th Congress. The findings of two studies are helping to advance understanding of the safety of biological therapies for psoriasis and reasons for COVID-19 vaccine hesitancy in psoriasis patients.
Researchers in Spain have studied sentiment towards COVID-19 vaccination in biologic-treated patients with psoriasis and/or psoriatic arthritis.1 The real-world data was collected via social media to minimise the limitations of traditional hospital surveys, which only capture data from motivated patients that could be impacted by the presence of a doctor.
10,922 social media posts were identified between January and March 2021 from patients in the USA, UK, France, Germany and Spain using pre-defined keywords, which were then filtered down to 624 posts to be manually analysed to derive insights.
Important findings suggest that COVID-19 vaccine hesitancy in patients was driven by safety concerns and concerns about aggravation of their underlying condition (n=344). Main factors driving this perception were potential side effects post-vaccination, effect on their autoimmune conditions and lack of trial data. Moreover, patients had no information on the interaction of the COVID-19 vaccine with biologic therapy and did not know what effect it had in immuno-compromised patients.
lvaro Gonzlez-Cantero of the Department of Dermatology Hospital Universitario Ramon Y Cajal, Madrid, Spain said: Looking forward, we know that we have to take these findings on board and educate patients on the importance, safety and effectiveness of the COVID-19 vaccine. Were hoping to be able to collaborate with an Academy like the EADV to help us tackle vaccine hesitancy through education.
Biologic treatments for psoriasis - a chronic inflammatory skin disease - are often associated with increased risk of infection. In a second real-word study, researchers in The Netherlands examined the differential effect of biological therapies on risk of respiratory tract infections (RTI) and serious infections (SI), including COVID-19, to help determine if any associations exist.2 A daily practice cohort of 714 psoriasis patients with 1325 treatment episodes from the BioCAPTURE registry was analysed, with 2224 RTI and 63 SI reported but only 1.3% of RTI reported as serious.
Analysis found no differential risk of RTI between included biologics adalimumab, etanercept, infliximab, ustekinumab, secukinumab, ixekizumab, and guselkumab, and no association was revealed for serious infections. Regarding SARS-CoV-2 infections, the crude incidence rate was 3.8 (95% CI: 2.2-6.1) per 100 PY during 2020, in a single BioCAPTURE centre.
Our analysis reveals no differences in risk of respiratory tract infections between biologics, including the newer IL-17 and IL-23 inhibitors, in a prospective psoriasis patients cohort. In addition, our preliminary results suggest that biological treatments do not impact psoriasis patients susceptibility to COVID-19 infections, although this needs to be further investigated, says Lara van der Schoot of the Department of Dermatology at Radboud University Medical Center, Nijmegen, The Netherlands, and Lead Author of the study. These findings provide key clinical value and will help to guide patient decisions with regard to psoriasis treatment options and choice.
The COVID-19 pandemic has posed an unprecedented challenge to patients with immune-mediated inflammatory diseases like psoriasis, shares Dee-Dee Murrell, EADV Board Member and Professor of Dermatology at the University of NSW, in Australia, However, the research presented here provides actionable insights that can help to educate and support psoriasis patients with regards to the impact of biological treatments on infection, and on the need for COVID-19 vaccinations.
END
Notes to Editors
A reference to the EADV 30th Congress or EADV Congress 2021 must be included when communicating any information within this press release.
Contact:
For further information or to arrange an expert interview, please contact:
Boryana Kermenova EADV Press Officer
+44 (0) 20 8971 6429
Catriona Martin EADV Press Officer
+44 (0) 20 8971 6412
About Psoriasis and Psoriatic Arthritis
Psoriasis
Psoriasis is a chronic, systemic immune-mediated inflammatory disease that causes raised plaques and scales on the skins surface.3 It can range in severity from a few scattered red, scaly plaques, to the involvement of almost the entire body surface it may also wax and wane in its severity over time.4 There are many different kinds of psoriasis, but the most common is plaque psoriasis which is found in 80% of people with the condition.5 Psoriasis affects between 2-3% of the worlds adult population, and <1% of children.6,7,8
Psoriatic arthritis
Psoriatic arthritis is a type of arthritis that affects some people with psoriasis. It typically causes affected joints to become swollen, stiff and painful.9 Arthritis is a common condition that causes pain and inflammation in a joint.10 Like psoriasis, psoriatic arthritis is a long-term condition that can get progressively worse. The severity can vary considerably however, if severe, there is a risk of the joints becoming permanently damaged or deformed.9 It usually develops between the ages of 30 and 50 and affects approximately 24 in 10,000 people. Between 5-10% of people with psoriasis develop psoriatic arthritis.11
About EADV
Founded in 1987, EADV is a leading European Dermato-Venereology Society with the important aims of improving the quality of patient care, furthering knowledge and education of dermatologists and venereologists and advocating on behalf of the speciality and patients. It is a non-profit organisation with nearly 7,000 members across 116 different countries in the world, providing a valuable service for every type of dermato-venereologist professional. To find out more visit https://www.eadv.org/.
About EADV 30th Congress 2021
The EADV's 30th Congress Anniversary Edition is a special celebration of three decades of science and innovation in the Dermatology and Venereology field. The 4-day Scientific Programme packed full with new findings and scientific breakthroughs and provides a unique opportunity to hear the latest in Dermato-Venereology and connect with leading experts. To find out more visit https://www.eadvcongress2021.org/.
References:
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Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients -...
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