MoonLake VELA Ph3: VELA-1 meets primary HiSCR75 (p<0.001); VELA-2 misses but shows significance on treatment policy

MoonLake Immunotherapeutics

VELA-1 achieved HiSCR75 at week 16 with 34.8% vs 17.5% placebo, delta 17.3% (p<0.001).
VELA-2 primary composite analysis p=0.053; pre-specified treatment policy gave 35.9% vs 25.6% (p=0.033).
Combined: HiSCR75 35.4% vs 21.6% (p<0.001); all secondary endpoints significant (pain, DLQI, HiSQOL).
Safety favorable: no suicidal ideation, MACE; oral candidiasis 7.3% on sonelokimab vs 0.4% placebo.
Next milestones: Q4 2025 LEDA (PPP), Q1 2026 S-OLARIS (axSpA), Q2 2026 VELA 52-week data.

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