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MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody sonelokimab in patients with active psoriatic arthritis – BioSpace

Posted: September 27, 2022 at 8:04 am

MoonLake Immunotherapeutics to initiate global Phase 2 studyofthe Nanobody sonelokimabin patients with active psoriatic arthritis

ZUG, Switzerland, September 26, 2022 MoonLake Immunotherapeutics AG (MoonLake), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced U.S. Food and Drug Administration (FDA) clearance for a Phase 2 clinical study of the nanobody sonelokimab in patients with active psoriatic arthritis (PsA). This is a global clinical study that also includes several European countries.

This new study is subsequent to the completion of a global Phase 2b study in moderate-to-severe psoriasis (NCT03384745) and the initiation of the Phase 2 MIRA study in moderate-to-severe hidradenitis suppurativa (NCT05322473).

The global, randomized, double-blind, placebo-controlled study (M1095-PSA-201, ARGO) is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. The primary endpoint of the study is the American College of Rheumatology (ACR) 50 response defined as the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo. This study is the first in PsA to use the Nanobody.

The study will also include a range of secondary endpoints reflecting the heterogeneous and multi-faceted nature of the disease, including the assessment of skin clearance (including Psoriasis Area and Severity Index (PASI) 100), disability, enthesitis, pain, as well as other levels of ACR response (including ACR70). Patient enrollment is expected to begin in 2022, with the first sites being initiated in Europe and in the United States.

Sonelokimab (M1095) is an investigational Nanobodydesigned to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to directly target sites of inflammation and penetrate difficult-to-reach inflamed tissues.

Kristian Reich,Co-founder andChief Scientific Officer at MoonLake, said: The initiation of the ARGO study represents an important milestone in the development of the IL-17A and IL-17F inhibiting Nanobody sonelokimab for the treatment of inflammatory skin and joint conditions. I am particularly excited to see how the small size and albumin-binding properties of sonelokimab will further elevate the anti-inflammatory potential of IL-17A and IL-17F inhibition to improve treatment outcomes across various disease domains of PsA including arthritis, enthesitis and psoriasis.

-ends-

About the ARGO studyThe ARGO study (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobodysonelokimab, administered subcutaneously, in the treatment of adult patients with active psoriatic arthritis. The study will comprise approximately 200 patients, and will evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm. The primary endpoint of the study is the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo, as measured by the American College of Rheumatology (ACR) 50 response. The study will also evaluate a number of secondary endpoints, including improvement compared to placebo in ACR70, complete skin clearance as measured by at least a 100 percent improvement in the Psoriasis Area and Severity Index (PASI100), physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis as measured by the Leeds Enthesitis Index and pain as measured by the Patients Assessment of Arthritis Pain (PtAAP).

About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The companys focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at http://www.moonlaketx.com.

About NanobodiesNanobodies represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and the ability to design multivalent therapeutic molecules with bespoke target combinations.

The terms Nanobody and Nanobodies are trademarks of Ablynx, a Sanofi company.

About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b study in 313 patients with moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated a rapid and durable clinical response (Investigators Global Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100) in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).

In an earlier Phase 1 study in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196203). Recently, a phase 2 trial in hidradenitis suppurativa (NCT05322473, M1095-PSA-201,MIRA) including multiple arms and over 200 patients has been initiated (announced on May 5, 2022).

Sonelokimab is not yet approved for use in any indication.

About Psoriatic ArthritisPsoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue.PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology.

Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLakes expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for preclinical studies, clinical trials and research and development programs; and the anticipated timing of the results from those studies and trials. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words anticipate, believe, continue, could, estimate, expect, intend, may, might, plan, possible, potential, predict, project, should, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLakes business in general and limited operating history, difficulty enrolling patients in clinical trials, and reliance on third parties to conduct and support its preclinical studies and clinical trials.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

MoonLake Immunotherapeutics InvestorsMatthias Bodenstedt, CFOinfo@moonlaketx.com

MoonLake Immunotherapeutics MediaPatricia Sousap.marquesdesousa@moonlaketx.com

Matthew Cole, Mary-Jane ElliottConsilium Strategic CommunicationsTel: +44 (0) 20 3709 5700media@moonlaketx.comMoonLake@consilium-comms.com

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How diversity and inclusion continues to be incorporated in dermatology – PMLiVE

Posted: at 8:04 am

Healthcare is an area where diversity and inclusion (D&I) can directly affect a persons quality of life and treatment outcomes. Recently in the field of dermatology, a focus on D&I is helping to redress historical bias and open avenues of research, bringing benefits to patients and healthcare systems alike.

Historically, medical textbooks have described skin symptoms in Caucasian-dominated language, based on lighter skin tones causing diagnosis and treatment disparities, with patients with darker skin tones being under-diagnosed and under-treated.1 Today, medical education programmes are rewriting textbooks, materials, and trainings to bridge this knowledge gap and reduce the chances of skin colour impacting accurate diagnosis and treatment. The British Association of Dermatologists highlighted the issue, noting that descriptors for rashes and lesions have been based on people of European ancestry.2 It observed that it is vital that the language used for describing rashes/lesions in dermatology is updated, to be inclusive and reflective of the UKs ethnic diversity. Demand is clear: a new clinical handbook of signs and symptoms in black and brown skin called Mind the Gap, has been viewed online more than 100,000 times.3

Janssen, as part of the pharmaceutical companies of Johnson & Johnson, has a 130-year heritage in healthcare. As we rise to the call to help address historical inequities, we are proud to take a multi-faceted approach which includes the active embedding of D&I principles throughout our organisation. In immunology, were reframing clinical trials, drug development, and support networks for patients suffering with chronic skin conditions and other diseases. D&I must be integral to beliefs and behaviours to be truly transformative in healthcare.

Dr Mehbub Shafi, Medical Advisor at Janssen-Cilag Ltd, notes changes seen since his medical training: Dermatological conditions affect patients of all skin tones, but symptoms can manifest differently, he says. While lack of awareness of these differences may have been an issue in the past, I can see that things are improving.

A clear example can be seen in psoriasis, an incurable chronic condition affecting 1.8 million people in the UK, 14 million Europe-wide and 125 million globally.4,5,6 The effects can be both physically and psychologically scarring. Research has shown that 37% of psoriasis patients experienced suicidal thoughts, while the impact on family members is evidenced by 37% of close relatives and partners reporting their relationships suffered because of the condition.7,8 Every aspect of life is impacted for example, people with psoriasis miss an average of 306 hours of work per year, more than eight weeks based on a 7.5-hour work day.9

Dr Shafi notes: There is the medical aspect, which is huge, but the psychological and psycho-social aspects are important too because patients living with a dermatological disease often have a higher incidence of mental health issues. Addressing diversity and inclusivity to achieve optimal treatment is pivotal in improving outcomes for patients with darker skin tones.

Diversity is relevant not just in psoriasis diagnosis, but also in treatment where, for example, higher doses of phototherapy may be needed for darker skin.10 Janssens UK medical education programme, aimed at and targeted to dermatologists across the UK, has focussed specifically on diversity and skin of colour. Janssen is also actively working with the UK dermatological community to develop resources supporting diagnosis and treatment in diverse communities,through partnerships with patient advocacy groups and patient advisors to ensure materials are tailored to diverse patient needs.

When it comes to decision-making in dermatological R&D, Janssen works with patients to enshrine the patient voice. This helps us deliver on the Johnson & Johnson credo: our first responsibility is to patients, doctors and nurses, followed by our responsibility to the communities in which we live and work, and then the global community, says Dr Shafi.

In addition to supporting better access to care, we are also raising awareness in the healthcare community about important issues in the diagnosis and treatment of diverse or under-represented groups. It is important to gain feedback from patients living with psoriasis and healthcare professionals, understanding their concerns and then implementing and driving activities that will have an impact.

At Janssen, the patient voice is central to pursuing novel research and improving therapies, to support work to stop and even cure dermatological diseases. Janssen will continue working with patients and experts to promote health equity for all as we work towards our mission to redefine treatments for dermatological diseases by delivering transformational and accessible therapies.

For more information, please visit http://www.janssen.com/uk

References

1 Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use. J Invest Dermatol 2015; 135(12): p2955-2963

2 British Association of Dermatologists. Improving Descriptors in Dermatology. Available at: https://www.bad.org.uk/healthcare-professionals/inclusivity-and-representation/descriptors-in-dermatology. Last accessed: September 2022

3 Dhillon R, Booth AJ & Mukwende M. Mind the Gap. British Dental Journal 2021; 230(273)

4 Psoriasis Association. About Psoriasis. Available at: https://www.psoriasis-association.org.uk/about-psoriasis. Last accessed: September 2022.

5 Augustin M, Alvaro-Gracia JM, et al. A framework for improving the quality of care for people with psoriasis. Psoriasis White Paper. JEADV 2012; 26(4): p1-16

6 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: September 2022

7 Pompili M, Innamorati M, et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. Journal of International Medical Research 2016; 44(1): p6166.

8 Eghlileb A, Davies E and Finlay A. Psoriasis has a major secondary impact on the lives of family members and partners. British Journal of Dermatology 2007; 156(6): p124550.

9 Mustonen A, et al. How much of the productivity losses among psoriasis patients are due to psoriasis. BMC Health Services Research 2015; 15(87)

10 National Psoriasis Foundation. Psoriasis and skin of color. 2021. Available at: https://www.psoriasis.org/advance/diagnosing-psoriasis-in-skin-of-color/. Last accessed: September 2022

Dr Mehbub Ali Shafi is Medical Adviser, Dermatology, The Janssen Pharmaceutical Companies of Janssen-Cilag Ltd.

* EM-80125 | September 2022

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How diversity and inclusion continues to be incorporated in dermatology - PMLiVE

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Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A – Benzinga

Posted: at 8:04 am

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Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A - Benzinga

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Pianist Paul Barnes and Native flutist Ron Warren to premiere piece Monday in Lincoln – Lincoln Journal Star

Posted: at 7:49 am

Pianist Paul Barnes and Native flutist Ron Warren discuss blended music that combines Indigenous musical ideas with western classical music during an interview on Friday, Sept. 23, 2022, in Lincoln, Neb.

Paul Barnes met Ron Warren in, of all places, North Dakota, when the Native flutist was called in to join Barnes, the Lincoln pianist, for a performance of Piano Concerto No. 2, After Lewis and Clark."

The performance of the piece that acclaimed composer Philip Glass wrote for Barnes began a creative collaboration between the musicians that extends to Monday night, culminating in the world premiere of The Way of Mountains and Desert, a solo piano piece Warren wrote for Barnes that will be the centerpiece of a program celebrating Warrens music.

Native flutistRon Warren (left) and University of Nebraska-Lincoln pianist Paul Barnes share a laugh as they rehearse at Westbrook Music Building on Friday.

R. Carlos Nakai played the Native flute when the concerto, commissioned for the Lewis & Clark Bicentennial, premiered at the Lied Center for Performing Arts in 2004. But Nakai wasnt available when Barnes was to perform the concerto with the Minot Symphony Orchestra in 2010 and suggested Warren as his replacement.

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It went so well, I swore that every subsequent performance that I had of the Glass work and weve played it in California and, of course, we played it twice here I always wanted to have Ron flown in from wherever he was, Barnes said.

Later, Barnes learned that Warren was a composer following a Jacksonville, Florida, concert that Warren drove from his Orlando-area home to attend.

I went up to hear Paul and it was his Greek Orthodox chant-based concert, Warren said. I was so taken with his singing and with Orthodox chant that I became really intrigued. So I had a flute phrase that kind of grew into a small piano piece that I sent off to Paul, just to thank him for that show. He played it for about a season.

That 2018 piece, Distances Between, will open Mondays concert and, appropriately, Barnes, Warren and Omaha Symphony bassist Danielle Meier will perform an arrangement of Sacagawea, the second movement of the Glass concerto that features the Native flute.

The second half of Mondays program will open with the new piece that Barnes commissioned from Warren.

Because I just love the way that Ron wrote for the piano, I wanted to commission a larger scale work, a big 20- to 25-minute work that would be kind of the focal point of performances, he said. Thanks to the Hixson-Lied College (of Fine and Performing Arts) I got my grant, Ron got paid and wrote this incredible, incredible piece for me.

What:"The Way of Mountains and Desert," celebrating the music of Ron Warren

Where: Kimball Recital Hall, 11th and R streets

When: 7:30 p.m. Monday

Admission: Free

The Way of the Mountains and Desert was inspired by a Barnes trip to the American Southwest for an Orthodox retreat, as well as indigenous poetry and Warrens own experiences.

Those experiences included playing in a deep gorge in Utah's Bryce Canyon National Park where reflections from a stream danced on the rock walls, giving Warren the idea for the high register, jumping, tinkling To Water, the pieces opening movement.

A lot of my music is the music of place anyway, of really trying to connect the beauty of a place and listening for what wants to be shared from that place, Warren said. So through a combination of our conversations, some of my favorite indigenous poets and my own memories from being in those places, what were calling the 'love song for the earth' grew as a flute song initially. From that grew the piano piece.

In Barnes Westbrook Music Building studio Friday, Barnes and Warren demonstrated how the flute song translates to the piano. While Barnes couldnt replicate the flutters of the flute and the piano added a low range of sounds, the graceful, flowing flute passage Warren played was largely replicated.

'I've always loved the way that Ron has played the flute, but I'm a pianist, so I never get to experience that," Barnes said. When he wrote this piano version of the flute song, it just felt so fluid. And I felt like I was actually a flute player.

Native flutistRon Warren rehearses Friday at Westbrook Music Building in Lincoln.

The concert will conclude with Beads, a four-movement duet between piano and Native flute that includes a section in which Warren gets to channel his inner Ian Anderson, the flutist of Jethro Tull fame.

That, too, could be heard during Fridays rehearsal, which vividly demonstrated how Native flute could be inserted into Western classical music, which Warren said isnt all that novel.

There are numerous indigenous musicians who, he said, are involved in every kind of music you can think of from classical piano to experimental electronic musicians building their own instruments.

The Way of Mountains and Desert, which Warren and Barnes will perform again in New York in May and likely play at concerts around the country over the next year, is a perfect example of something vibrantly new.

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