MoonLake Receives FDA Clearance for Sonelokimab BLA Submission in Hidradenitis Suppurativa Without Additional Trials
Key Insights
MoonLake Immunotherapeutics received positive FDA feedback confirming the company can establish substantial evidence of effectiveness for sonelokimab in hidradenitis suppurativa (search) using existing VELA-1, VELA-2, and MIRA trial data without conducting additional clinical studies.
The FDA specifically advised including MIRA trial results in the BLA submission and recommended submitting VELA-2 data to inform the safety profile, regardless of its utility in establishing effectiveness.
Based on the Type B meeting outcomes, MoonLake will proceed with BLA submission for sonelokimab in hidradenitis suppurativa (search) in the second half of 2026.
MoonLake Immunotherapeutics announced positive outcomes from a Type B meeting with the U.S. Food and Drug Administration (search), receiving regulatory clarity that enables the company to proceed with a Biologic License Application (BLA) for sonelokimab in hidradenitis suppurativa (search) without conducting additional clinical trials. The FDA confirmed that MoonLake may establish substantial evidence of effectiveness using data from its existing VELA-1, VELA-2, and MIRA trials, encompassing over 1,000 patients with moderate-to-severe hidradenitis suppurativa.
FDA Provides Clear Regulatory Path Forward
The FDA specifically advised MoonLake to include results from the MIRA trial in the BLA submission and to submit VELA-2 trial data for the marketing application to inform the safety profile of sonelokimab, regardless of decisions on its utility in establishing substantial evidence of effectiveness. The agency excluded using mechanistic evidence as confirmatory evidence in combination with results from a single clinical trial to establish effectiveness for the hidradenitis suppurativa (search) indication.
Dr. Jorge Santos da Silva, Founder and Chief Executive Officer at MoonLake Immunotherapeutics, stated: "The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required. In addition, the fact that we can prepare the BLA with the wealth of data across the VELA and MIRA trials provides us and the FDA with flexibility to determine the best label possible."
Strong Clinical Performance Across Multiple Trials
Sonelokimab demonstrated significant improvements across different key outcomes in the comprehensive clinical program. The MIRA trial, which was the first placebo-controlled randomized clinical trial in hidradenitis suppurativa (search) using HiSCR75 as the primary endpoint, achieved a 43% response with 120mg sonelokimab and a 29 percentage point delta versus placebo (p < 0.001) at week 12.
In the VELA-1 trial, sonelokimab met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies, achieving HiSCR75 at Week 16 with a 35% response rate for the 120mg dose and a 17 percentage point delta to placebo (p < 0.001). VELA-2 achieved statistical significance using the pre-specified treatment policy strategy, with HiSCR75 at Week 16 showing a 36% response with 120mg sonelokimab and a 10 percentage point delta to placebo (p = 0.033). A higher-than-expected placebo response prevented this study from achieving statistical significance using the primary composite analysis method, with a delta to placebo of 9% (p=0.053).
All trials consistently demonstrated a favorable safety profile of sonelokimab in hidradenitis suppurativa (search) patients, with no new safety signals detected across the clinical program.
Comprehensive Development Program Continues
Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake Immunotherapeutics, commented: "The FDA recognizes that MIRA and VELA-1, which met their primary and important key secondary endpoints, together with VELA-2, can be used to establish substantial evidence of effectiveness, and that VELA-2 provides a key source of evidence to inform, for example, the safety of sonelokimab."
The company plans to submit the BLA in the second half of 2026, maintaining its previously announced timeline. MoonLake will hold an Investor Day on February 23rd, 2026, to discuss the FDA meeting outcomes and present new clinical data for sonelokimab across indications.
Robust Clinical Pipeline and Upcoming Milestones
Beyond hidradenitis suppurativa (search), MoonLake's clinical program includes multiple ongoing trials. The company expects primary endpoint readout from the Phase 2 S-OLARIS trial in axial spondyloarthritis (search) in Q1 2026, followed by 52-week data from the VELA-1 and VELA-2 trials in Q2 2026. Mid-2026 will bring primary endpoint readouts from both the Phase 3 IZAR-1 trial in psoriatic arthritis (search) and the Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa.
The company is also conducting a long-term Phase 3 study evaluating the safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (search) who completed earlier MoonLake studies. This open-label, single-arm trial tracks long-term outcomes with sonelokimab administered every four weeks.
Sonelokimab is an investigational ~40 kDa humanized Nanobody consisting of three VHHs that selectively binds with high affinity to IL-17A and IL-17F (search), thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The drug's unique mechanism targets the IL-17 pathway, which has increasing scientific evidence supporting its role as a key driver in hidradenitis suppurativa (search) pathogenesis.