Category Archives: Transhuman News

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S a global leader in medical dermatology announced today that the first patient has been screened in the first head-to-head clinical trial to evaluate brodalumab (marketed in the European Union as Kyntheum) compared with guselkumab (marketed globally as Tremfya) in adult patients with moderate-to-severe plaque psoriasis who have an inadequate response to ustekinumab (marketed globally as Stelara) treatment.

The COBRA (COmparing BRodalumab And guselkumab in ustekinumab inadequate responders) clinical trial is a randomized, double-blind, parallel-group, multinational study. The primary study endpoint is the proportion of patients who achieve PASI 100 (100% skin clearance) at week 16. The study further includes several secondary and exploratory endpoints, including the key secondary endpoint of time to PASI 100 response while on treatment for up to 28 weeks. PASI scores are used in clinical trials for psoriasis treatments to measure a change in disease severity.

People with moderate-to-severe psoriasis benefit from complete skin clearance, said Prof. Kristian Reich, Professor for Translational Research in Inflammatory Skin Disease at the University Medical Center Hamburg Eppendorf. We have specifically designed this study to help understand which newer mechanism of action is the best option to help patients potentially achieve complete skin clearance when there is an insufficient response to older-generation biologics.

Brodalumab is the only biologic treatment that selectively targets the interleukin-17 (IL-17) receptor subunit A.1 The IL-17 cytokines a family of proteins involved in immune responses send signals through the IL-17 receptors, which cause the inflammation associated with psoriasis.2

Guselkumab is a biologic treatment that selectively targets the interleukin 23 (IL-23) cytokine. IL-23 affects the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.3

We look forward to learning how brodalumab, in comparison with a treatment that targets the IL-23 pathway, can offer benefits to patients who no longer respond to less targeted therapies, said Dr. Per Sproegel, Vice President, Medical Sciences, Global Research & Development, LEO Pharma.

#ENDS#

NOTES TO EDITORS

About the pathophysiology of psoriasis

Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.4 The discovery of the central role of the IL-23/type 17 T-cell axis in the development of psoriasis has led to major paradigm shifts in the pathogenic model for this condition.4 Medical research has further confirmed that the expression of IL-17 cytokines is increased in psoriatic lesion tissue.5

About LEO Pharma

The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit http://www.leo-pharma.com.

References

1 Campa M et al. Dermatol Ther 2016;6:112.

2 Armstrong A et al. J Drugs Dermatol 2019;18(8 Suppl 2):s202-208.

3 Tremfya Summary of Product Characteristics January 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf (Accessed September 2020).

4 Hawkes JA et al. J Allergy Clin Immunol. 2017;140:64553.

5 Martin D et al. J Invest Dermatol 2013;133(1):17-26.

See the original post:
LEO Pharma initiates head-to-head study to evaluate brodalumab vs. guselkumab in adult patients with moderate-to-severe psoriasis who have inadequate...

If you can identify leading companies in growing industries, you'll be well on your way to finding stocks that will bolster your portfolio's value. Beyond that, it helps to pick companies that have investor-friendly policies -- not to mention favorable tailwinds or upcoming catalysts for growth.

In that vein, after an excellent 2020, the pharma company AbbVie (NYSE:ABBV) is positioned for an encore performance in 2021. Its quarterly revenue is growing faster than 52% year over year, and the company is strongly profitable thanks to its collection of in-demand immunology and rheumatology therapies. But despite three green flags for the upcoming year, it also has one looming red flag that future investors absolutely can't miss if they want to make an informed decision about buying shares. Let's dive in and take a look at what's coming up.

Image source: Getty Images.

Rinvoq, one of AbbVie's drugs for rheumatoid arthritis, is already on the market. But in 2021, it may be approved for as many as three new indications, thereby increasing its pool of potential patients and its revenue-making potential, too.

AbbVie is currently awaiting regulatory review of its evidence that Rinvoq is effective for psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis. The potential approval for atopic dermatitis is especially important, as it would mean that the company could serve a new market that it currently has no presence in.

Sometime this year, AbbVie will provide an update from Skyrizi's phase 3 clinical trial for Crohn's disease. If this update is favorable, it'll mean that the company is continuing to see success with its efforts to build out its immunology pipeline by seeking new indications of its established assets. Given that the global market for Crohn's disease therapeutics was estimated to be worth $14.1 billion in 2020, the company could potentially look forward to a slice of the market share moving forward.

The bigger picture here is that advancing rapidly with Skyrizi will help AbbVie replace revenue from Humira, the decline of which has loomed for years. Right now, Skyrizi is already approved for psoriasis, and there are ongoing clinical trials to examine its effectiveness for ulcerative colitis and psoriatic arthritis. If it's ultimately approved for those indications, it'd be capable of serving the majority of the markets addressed by Humira.

AbbVie's drug Humira for rheumatoid arthritis is its largest earner, netting the company an estimated $16 billion from its U.S. sales in 2020 alone. And management expects domestic revenue from Humira to keep expanding in 2021, even as it faces rising competition from biosimilars.

Another way of looking at this green flag is that biosimilars haven't eroded Humira's market share as rapidly as many people had expected. Therefore, AbbVie has a bit more time before sales from Humira fall off the cliff. So investors can have a measure of confidence that AbbVie won't need to take defensive financial actions like curbing its dividend anytime soon.

Even though AbbVie is still seeing revenue growth from Humira in the U.S., the same is not true when it comes to international sales. Continuing a trend that started with gusto in 2018 when Humira lost patent exclusivity in Europe, biosimilars will erode Humira's market share throughout 2021 outside the U.S., with management estimating a sharp drop of 45% this year.

In dollar values, this means that after making $3.7 billion in international sales in 2020, this year Humira could make as little as $1.5 billion. That's going to leave a small but noticeable dent in the company's trailing 12-month revenue of $40.65 billion. But if it succeeds in getting its other immunology projects to pick up its market share where Humira leaves off, its stock price could still be secure for the time being.

The rest is here:
3 Green Flags for AbbVie in 2021 and 1 Red Flag - The Motley Fool

James Woody, CEO of180 Life Sciences, pictured above. Photo courtesy of 180 Life Sciences.

Despite a storied career in drug design that has spanned multiple decades, James Woody believes there is still a significant amount of work left to be accomplished with the development of tumor necrosis factor (TNF) inhibitor biologics.

Im excited about developing novel therapies for patients and Im also excited about just discovering things, Woody said in an interview with BioSpace ahead of the virtual J.P. Morgan Healthcare Conference.

Woody, who now serves as chief executive officer of 180 Life Sciences, began his career in drug development as the chief scientific officer and head of research and development at Centocor Biotech, now a part of the Johnson & Johnson family.

During his time at Centocor, Woody led the team responsible for developing Remicade, the first of the TNF inhibitor biologics, which has gone on to become a blockbuster drug with sales of $5 billion in 2019.

Woody was also the founding CEO of OncoMed Pharmaceuticals, Inc. and served as president at Roche Bioscience, where he was responsible for all bioscience research and development, ranging from genetics and genomics to clinical development of numerous new pharmaceuticals.

TNF inhibitors, such as Remicade, are used to stop inflammation. They are popular treatments in disease like rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis (UC) and Crohn's disease.

Woody said spaces like RA are pretty well covered, but noted there are other areas where this type of medication could benefit millions of people, such as early Dupuytren's contracture, a fibrotic disease of the hand. There are approximately 11 million people in the United States, including Woodys wife, and a similar number in Europe who are afflicted with this painful condition that can cause the hand to curl up into a claw.

180 Life Sciences is currently assessing its TNF inhibitor in a Phase II/III program. Results from this study are expected in the second half of this year. Obtaining results from the ongoing study have been delayed due to the COVID-19 pandemic, Woody said.

Another space 180 is assessing its anti-TNF program is in frozen shoulder, a condition characterized by stiffness and pain in the shoulder joint. Woody said this is an extremely painful condition due to fibrosis in the shoulder joint. They believe the fibrosis process is similar to what has been seen in early Dupuytren's contracture and will assess the companys anti-TNF asset during a study expected to begin in the third quarter of this year.

The third area for 180s anti-TNF program is in post-operative cognitive delirium disorder and dysfunction. This issue arises in older patients who have been under anesthesia for an extended period of time due to some surgical procedures. After the surgery or during the surgery, TNF can be released, which is a cause of dementia, Woody said. The company believes its program can be useful to prevent this condition and will conduct a study using their novel concepts.

In addition to those three areas, Woody said the company is also looking at nonalcoholic steatohepatitis (NASH) as a potential area for its anti-TNF therapy. NASH has been a difficult area for drug developers to crack, but Woody believes his team has found a new approach. Using human tissue from surgeries, 180 Life Sciences research team has been examining the pathways of damage in the liver and they believe a release of TNF plays a role in that damage.

We think we can block that. We definitely need some therapies for NASH, thats for sure, Woody said.

180 Life Sciences also has some interesting programs in preclinical development. The company has a program using pharmaceutical-grade oral synthetic cannabidiol analogs to treat pain that is specifically focused on arthritis. Woody expects this asset to enter the clinic next year. 180 Life Sciences also has an 7 Nicotinic Acetylcholine receptor agonist program, which aims to develop 7nAChR agonists for the treatment of inflammatory diseases, initially ulcerative colitis induced after cessation of smoking.

One of the co-developers of Remicade, Sir Marc Feldmann, a pioneer in anti-TNG therapies, is also part of Woodys team at 180 Life Sciences. Feldmans research helped lead to not only the development of Remicade, but it was also licensed by AbbVie to develop Humira, Woody said. Feldman is intimately involved in the development of two of the three projects being developed by 180 Life Sciences, and is also exploring new uses of anti-TNF and synthetic cannabidiol analogues. Feldman serves as co-chairman of the companys board of directors.

Feldman isnt the only noted researcher to join with 180 Life Sciences. Lawrence Steinman, a professor of Neurology and Pediatrics at Stanford University, whose research led to the development of multiple sclerosis drug Tysabri, serves as co-chairman of the companys board of directors.

Most Read Today

More:
180 Life Sciences Poised to Break Ground with Anti-TNF Program - BioSpace

's () Stuart Ashman talks to Proactive London about their wholly-owned subsidiary AxisBiotix Limited which is getting ready for their food supplement consumer study.

The study, which will accept around 200 applicants, the participants will be asked to take a powdered food supplement dissolved in a glass of water on a daily basis and the study will run for a total of 56 days (2 x 28-day blocks).

The supplements have been manufactured by Winclove and are currently being packaged ahead of shipment to the company in early February.

Ashman talks through in detail their drive for commercialisation, with talks already underway.

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of SkinBioTherapeutics PLC named herein, including the promotion by the Company of SkinBioTherapeutics PLC in any Content on the Site, the Company...

Continue reading here:
Skinbiotherapeutics get set for live data trial to target skin conditions including psoriasis - Proactive Investors UK