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
- Guselkumab Demonstrates Significant Improvement in Psoriasis Symptoms and HRQoL, Reduces Sexual Impairment ... - Dermatology Times - April 18th, 2024 [April 18th, 2024]
- Psoriasis Patients with Arthralgia At Increased Risk of Psoriatic Arthritis Development - MD Magazine - April 18th, 2024 [April 18th, 2024]
- Diagnosing Psoriatic Arthritis for the Dermatologist: Guidance From the Experts - Medscape - April 18th, 2024 [April 18th, 2024]
- Secukinumab 300 mg May Improve PsA or Active Psoriasis More Than 150 mg - MD Magazine - April 18th, 2024 [April 18th, 2024]
- The Impact of Pediatric Plaque Psoriasis on Children and Caregivers - HMP Global Learning Network - April 18th, 2024 [April 18th, 2024]
- Guselkumab Led to Improvements Over Several Psoriatic Arthritis Disease Domains - MD Magazine - April 18th, 2024 [April 18th, 2024]
- Dual Diagnosing and Managing Psoriasis and Psoriatic Arthritis - The Dermatologist - April 18th, 2024 [April 18th, 2024]
- Etanercept Effective for Psoriasis, Rheumatic Disease Among Patients Extending Treatment After 12-Weeks - MD Magazine - February 9th, 2024 [February 9th, 2024]
- High Response Rates in Psoriasis With Oral IL-23 Inhibitor - Medpage Today - February 9th, 2024 [February 9th, 2024]
- Psoriasis and eczema have complex causes and consequences that researchers are seeking to uncover - Medical Xpress - February 9th, 2024 [February 9th, 2024]
- New Hope in Treatment of Plaque Psoriasis: Study Shows Promising Results - Medriva - February 9th, 2024 [February 9th, 2024]
- No Difference in Psoriasis Immune Response Despite Switch Between AVT02, Adalimumab - MD Magazine - February 9th, 2024 [February 9th, 2024]
- Oral IL-23 Receptor Antagonist Peptide Effective in PASI Reduction for Psoriasis - MD Magazine - February 9th, 2024 [February 9th, 2024]
- Breakthrough in Psoriasis Treatment: JNJ-77242113 Shows Promising Results - Medriva - February 9th, 2024 [February 9th, 2024]
- Promising Results from Phase II Trial of Oral Interleukin Inhibitor for Psoriasis Treatment - Medriva - February 9th, 2024 [February 9th, 2024]
- Promising Results from the FRONTIER 1 Trial - An Exploration of JNJ-77242113 in the Treatment of Moderate-to ... - Medriva - February 9th, 2024 [February 9th, 2024]
- Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva - February 9th, 2024 [February 9th, 2024]
- Rising Cost of Stelara: Impact on Patients and Johnson & Johnson's Market Performance - Medriva - February 9th, 2024 [February 9th, 2024]
- Global Psoriatic Arthritis (PsA) Treatment Market to achieve a remarkable US$ 15.6 Billion by 2028, - PharmiWeb.com - February 9th, 2024 [February 9th, 2024]
- Tremfya potential highlighted by industry analyst GlobalData - The Pharma Letter - May 31st, 2023 [May 31st, 2023]
- Stress Leads to Increased Risk of Depression, Anxiety for Psoriasis ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Janssen Announces Positive Results From Guselkumab Psoriatic ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Early Intervention with Secukinumab May Be Effective for Patients ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- VEGF-A Inhibition Downregulates Blood Vessel Area in Psoriasis - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Scratching the itch, Lynk Pharmaceuticals trialling ointment for ... - OutSourcing-Pharma.com - May 31st, 2023 [May 31st, 2023]
- Brepocitinib More Efficacious Than Placebo in Long-Term Psoriatic ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- For Patients With Birthmarks, Psychosocial Interventions Improved ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Robert Hariri, MD: Natural Killer Cell Therapy Shows Remarkable ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Nalbuphine ER Tablets Show Promise as Cough Therapy in ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Benefit of Empagliflozin in HFpEF Consistent Regardless of Diuretic ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- selectION reports results from SAD stage of si-544 Phase Ib trial - Clinical Trials Arena - May 31st, 2023 [May 31st, 2023]
- No Link Observed Between Gastrointestinal Tract Surgery and New ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Lynk doses first cohort in Phase Ib trial of psoriasis therapy - Clinical Trials Arena - May 30th, 2023 [May 30th, 2023]
- Metabolic Inflammation Contributes to Depression in Psoriatic Disease - Dermatology Times - May 30th, 2023 [May 30th, 2023]
- Encouraging Diversity and Inclusion for Patients With Psoriatic ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- The Weekly Roundup: May 22-26 - Dermatology Times - May 30th, 2023 [May 30th, 2023]
- Pediatric Psoriasis Market: A Study of the Industry's Key Applications ... - The Navajo Post - May 30th, 2023 [May 30th, 2023]
- Phototherapy Lamps Market are set to witness a CAGR of 5.8 ... - Digital Journal - May 30th, 2023 [May 30th, 2023]
- Celltrion seeks approval for Stelara biosimilar in EU - The Investor - May 30th, 2023 [May 30th, 2023]
- Peter Marinkovich, MD: FDA Approval of B-VEC Gene Therapy for ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Nick Stucky, MD, Phd: Implications for Media Influence on Minoxidil ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Tildrakizumab Linked With HRQOL Improvement in Psoriasis in a Real-World Setting - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- Clinical Utility of Deucravacitinib for the Management of Moderate to ... - Dove Medical Press - May 18th, 2023 [May 18th, 2023]
- Covid-19 and Psoriasis: Is there a link? - Dunya News - May 18th, 2023 [May 18th, 2023]
- Improvement Needed in Study Interventions to Better Skin Self ... - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- Reviva Pharmaceuticals Announces Intent to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data - Marketscreener.com - May 18th, 2023 [May 18th, 2023]
- Adam Friedman, MD: Addressing Disparities in Care for Patients ... - MD Magazine - May 18th, 2023 [May 18th, 2023]
- Early-Infancy Meningitis Infection Linked With Increased Risk of ... - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- NOVN: Counting Down to PDUFA - Yahoo Finance - May 18th, 2023 [May 18th, 2023]
- Psoriatic Arthritis (PsA) Treatment Market is likely to register CAGR ... - Future Market Insights - May 18th, 2023 [May 18th, 2023]
- New campaign raises awareness of topical steroid withdrawal - Professional Beauty - May 18th, 2023 [May 18th, 2023]
- MoonLake Immunotherapeutics completes patient enrollment and randomization ahead of schedule in a Phase 2 trial of the Nanobody sonelokimab in... - February 2nd, 2023 [February 2nd, 2023]
- EVELO BIOSCIENCES, INC. : Costs Associated with Exit or Disposal Activities, Change in Directors or Principal Officers, Other Events (form 8-K) -... - February 2nd, 2023 [February 2nd, 2023]
- 12 Ways to Treat Psoriasis at Home - Healthline - January 22nd, 2023 [January 22nd, 2023]
- DTC Advertising Of Prescription Drugs In The U.S. Often Promotes Products With Comparatively Low Therapeutic Value - Forbes - January 19th, 2023 [January 19th, 2023]
- Types of Psoriasis: Pictures, Symptoms and Treatments - Healthline - December 18th, 2022 [December 18th, 2022]
- Psoriasis Pathogenesis and Treatment - PMC - PubMed Central (PMC) - November 23rd, 2022 [November 23rd, 2022]
- Drug-Provoked Psoriasis: Is It Drug Induced or Drug Aggravated? - November 23rd, 2022 [November 23rd, 2022]
- Im a Dermatologist and These 7 Things Could Be Making Your Psoriasis Worse - Well+Good - October 19th, 2022 [October 19th, 2022]
- 'Worst time of the year for me to be covered in scabs': Amber Heard's Alleged Ex Cara Delevingne Revealed Her Psoriasis Struggle Made Kate Moss Scream... - October 19th, 2022 [October 19th, 2022]
- Psoriasis: What It Is, Symptoms, Causes, Types & Treatment - October 17th, 2022 [October 17th, 2022]
- What is psoriasis and which foods ease symptoms? - Evening Standard - October 17th, 2022 [October 17th, 2022]
- Chronic inflammatory diseases: what they are - Emergency Live International - October 17th, 2022 [October 17th, 2022]
- How remote care can deliver a step change in treatment for inflammatory skin conditions - PoliticsHome - October 17th, 2022 [October 17th, 2022]
- Probiotics Supplementation may Improve Symptoms of Hyperuricemia and Gout - Rheumatology Network - October 15th, 2022 [October 15th, 2022]
- Psoriasis Pathogenesis and Treatment - PubMed - October 2nd, 2022 [October 2nd, 2022]
- Best and Worst Drinks for Psoriasis - Everyday Health - October 2nd, 2022 [October 2nd, 2022]
- These Are the 10 Most Common Chronic Skin Conditionsand the Most Important Facts to Know About Them - Parade Magazine - October 2nd, 2022 [October 2nd, 2022]
- Survey Addresses Concerns Regarding Reproductive Healthcare Communication in Women with RA, PsA - Rheumatology Network - October 2nd, 2022 [October 2nd, 2022]
- Psoriasis Types, Symptoms & Causes | NIAMS - September 29th, 2022 [September 29th, 2022]
- What Is Psoriasis And Can It Be Treated? - Forbes - September 29th, 2022 [September 29th, 2022]
- Plaque Psoriasis Treated With Tildrakizumab Shown to be Effective in Real-World Settings - MD Magazine - September 29th, 2022 [September 29th, 2022]
- Alumis Announces Initiation of Patient Dosing in Phase 2 Clinical Trial of ESK-001 for the Treatment of Plaque Psoriasis - Business Wire - September 29th, 2022 [September 29th, 2022]
- 15 Items That Will Make Your Life With Psoriatic Arthritis Easier - BlackDoctor.Org - September 29th, 2022 [September 29th, 2022]
- Types of Psoriasis and Their Effects on the Immune System - Cureus - September 27th, 2022 [September 27th, 2022]
- How diversity and inclusion continues to be incorporated in dermatology - PMLiVE - September 27th, 2022 [September 27th, 2022]
- Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A - Benzinga - September 27th, 2022 [September 27th, 2022]
- Psoriasis Treatment Market Size to Hit USD 51.24 Bn by 2030 - GlobeNewswire - August 15th, 2022 [August 15th, 2022]
- Ventyx Sees Initiation Of Mid-Stage Psoriasis Study In Q4 2022 Following Positive Data From Initial-Stage - Benzinga - August 15th, 2022 [August 15th, 2022]
- Woman, 29, Slams Bullies Who 'Giggle And Whisper' At Her Unsightly Psoriasis Sores And Scabs, Leaving Her Depressed And 'Struggling To Walk' -... - August 15th, 2022 [August 15th, 2022]