MoonLake to file HS drug on data with a missed Phase 3 endpoint
MoonLake plans a September 2026 BLA for sonelokimab in hidradenitis suppurativa built on two pivotal trials, one of which missed its primary endpoint at Week 16.
Executive Summary
- MoonLake is proceeding toward a hidradenitis suppurativa BLA built on a pivotal program where one of two late-stage trials did not hit its primary endpoint at the pre-specified timepoint, with the agency having already agreed the broader data package can support submission.
- The filing leans on durability data collected well past the point where the primary analysis fell short, plus a companion trial that succeeded and an earlier Phase 2 study, to construct the effectiveness argument.
- FDA's pre-BLA sign-off on this data package, and its acceptance of adolescent data to broaden the label, are the more consequential facts here than the calendar date of the submission itself.
- Hidradenitis suppurativa has no approved IL-17-pathway therapy yet, and MoonLake's dual IL-17A/F mechanism sits ahead of, not behind, other IL-17A programs still in earlier or non-registrational testing in the disease.
The submission plan
MoonLake said its April 1, 2026 final pre-BLA meeting with the FDA produced agreement on submission plans and label strategy for sonelokimab in hidradenitis suppurativa, with the BLA now planned for the end of September 2026 and an acceptance decision, including whether Priority Review will apply, expected by the end of November 2026. The FDA re-confirmed that data from the Phase 2 MIRA trial (NCT05322473) can be used to establish evidence of effectiveness sufficient to support the filing, and agreed to include VELA-TEEN adolescent data (NCT06768671) to support a label covering patients 12 and older. MoonLakeMoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the ...May 10, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The endpoint that missed
The pivotal package rests on two identically designed Phase 3 trials in adults, VELA-1 (NCT06411899) and VELA-2 (NCT06411379), each enrolling around 420 patients against placebo with HiSCR75 (Hidradenitis Suppurativa Clinical Response 75, at least 75% reduction in inflammatory lesions) as the primary endpoint. VELA-1 met its primary endpoint. VELA-2, the trial tied to this filing catalyst, did not: it missed its prespecified Week 16 HiSCR75 analysis at p=0.053, narrowly outside conventional statistical significance. VELA-2 completed enrollment at 418 patients, unchanged in proportion from its original 400-patient target, and moved from Active, not recruiting to Completed status on June 8, 2026, a routine registry update rather than an operational red flag. NCT06411379Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaNCT06411379
What the durability data add
MoonLake reported that VELA-2 responses continued to build past the missed Week 16 mark, reaching 66.0% HiSCR75 and 35.1% HiSCR100 at Week 52, with no new safety signals disclosed. VELA-1's Week 52 data showed 68.3% HiSCR75 with sustained quality-of-life improvement. The earlier Phase 2 MIRA trial reported roughly 43% HiSCR75 response and a 29-percentage-point delta over placebo at Week 12, which MoonLake said are the highest values observed across any adequately controlled hidradenitis suppurativa trial to date, and the proposed label is expected to lead with that MIRA result rather than the VELA-2 primary analysis. MoonLakeMoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the ...May 10, 2026
Competitive setting
No IL-17-pathway therapy is approved for hidradenitis suppurativa. Novartis's secukinumab, also an IL-17A inhibitor, is running a Phase 4 trial in the same indication (NCT07489573), and UCB's bimekizumab, which also targets IL-17A, is furthest along in the related indication of plaque psoriasis (NCT06425549). Sonelokimab is differentiated within this class as a nanobody that neutralizes both IL-17A and IL-17F, rather than IL-17A alone, and MoonLake is already running two additional Phase 3 sonelokimab trials in hidradenitis suppurativa (NCT07007637, NCT06768671) alongside a Phase 3 program in psoriatic arthritis. Of the five Phase 3-or-later hidradenitis suppurativa trials targeting IL-17A tracked to a resolved outcome, one met its primary endpoint and one did not.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.