Press release
MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day
MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":" MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day Positive 24-week data from the ARGO trial of sonelokimab in PsA:Significant improvements observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an ACR50 response at week 24Unprecedented multi-domain responses across joints, skin and other domains, including up to 52% of patients achieving ACR50+PASI100 and up to 61% of patients achieving Minimal Disease Activity (MDA), supporting potential best-in-class profile of sonelokimabMonthly maintenance with 60mg or 120mg doses showed leading responses above TNF reference arm across all key outcomes including in higher treatment goals (ACR70, PASI100, composites) – 120mg added benefit for specific patient subgroupsLow discontinuation rate around 5% and safety profile of sonelokimab consistent with previously reported studies with no new safety signalsUpdate on sonelokimab in hidradenitis suppurativa (HS):Following interactions with the FDA and EMA, MoonLake intends to commence Phase 3 trials in HS in Q2 2024, under the VELA program; the program is expected to enroll 800 patients and reflect a similar protocol design to that used in the MIRA Phase 2 trial, with top-line primary endpoint data expected as early as mid-2025Real-world data indicates that at least 2 million Americans have been diagnosed with HS as of 2023, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity exceeding $10bn by 2035 MoonLake further announces that it will imminently commence four additional clinical trials of sonelokimab across dermatology, and rheumatology, including innovative trials in palmo-plantar pustulosis, juvenile HS and seronegative spondyloarthritisThe Company is hosting an R&D Day on Sunday, March 10 at 09:00 PDT/12:00 EDT/17:00 CET via webcast (registration link below), alongside the American Academy of Dermatology (AAD) annual meeting ZUG, Switzerland, March 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that continued treatment with Nanobody® sonelokimab led to significant improvements across all k...