Moonlake Immunotherapeutics has released significant data from the Argo trial of its nanobody® Sonelokimab in the treatment of psoriatic arthritis (PSA). The 24-week data from the trial demonstrated significant improvements across all key outcomes, with approximately 60% of patients achieving an ACR50 response by week 24. The trial also showed unprecedented multi-domain responses across joints, skin, and other domains, indicating the potential best-in-class profile of Sonelokimab.
Moonlake also intends to commence Phase 3 trials for Sonelokimab in Hidradenitis Suppurativa (HS) in Q2 2024, with the program expected to enroll 800 patients. Real-world data indicates that at least 2 million Americans have been diagnosed with HS as of 2023, highlighting a significant unmet need and a market opportunity exceeding $10 billion by 2035.
Moonlake will also commence four additional clinical trials of Sonelokimab across dermatology and rheumatology, including innovative trials in palmo-plantar pustulosis, juvenile HS, and seronegative spondyloarthritis.
The 24-week results from the Argo trial build upon the 12-week results announced in November 2023, and the full results will be submitted for publication in a peer-reviewed medical journal.
In the HS market, Moonlake's end-of-phase 2 interactions with the FDA and EMA have been successful, with both regulatory bodies supporting the proposed approach for advancing Sonelokimab into Phase 3 trials. Real-world data analysis revealed that the HS market size could exceed $10 billion by 2035, indicating a significant market opportunity.
Moonlake will also commence four additional development programs, including work in dermatology and rheumatology, where IL-17A and IL-17F inhibition in deep tissues has the potential to lead among all therapies.
The company is hosting an R&D day, highlighting the 24-week Argo data, regulatory interactions, and paths to Phase 3, alongside other important business updates from the executive team.
Finally, the 24-week data from the Phase 2 MIRA trial with Sonelokimab in moderate to severe HS will be presented during the late-breaking research session at the AAD annual meeting.
Moonlake's nanobody Sonelokimab has shown significant potential in the treatment of PSA and HS, with positive data and regulatory support paving the way for further clinical trials and potential commercialization. The market has reacted to these announcements by moving the company's shares 1.8% to a price of $46.44. If you want to know more, read the company's complete 8-K report here.
