MoonLake shares crash after mixed results in pivotal hidradenitis suppurativa studies
MoonLake Immunotherapeutics' lead drug, sonelokimab, failed to meet expectations in two pivotal Phase 3 studies for hidradenitis suppurativa, sending shares down more than 80%1.
In one trial, 35% of patients treated with sonelokimab achieved significant symptom reduction versus 18% for placebo, but the effect size was less than hoped and considered poorly competitive against existing treatments1.
Sonelokimab did not meet its primary endpoint in the second Phase 3 study, which the company attributed to an unexpectedly strong placebo response1.
Analysts downgraded expectations for the drug's approval and market potential, describing the results as 'disappointing' and unlikely to differentiate sonelokimab from competitors such as AbbVie's Humira, UCB's Bimzelx, and Novartis' Cosentyx1.
MoonLake had previously claimed that sonelokimab's trispecific mechanism and small molecular size could improve potency and duration, but trial results did not demonstrate clear superiority over recently approved IL-17 inhibitors1.
MoonLake plans to discuss possible regulatory pathways with health authorities, but analysts believe a clear approval path is unlikely in the near term1.
MoonLake's share price fell dramatically, dropping from about $62 to below $10 following the news1.
Hidradenitis suppurativa is a chronic, painful inflammatory skin condition with significant unmet medical need and competing emerging therapies4.
Sources:
1. https://www.biopharmadive.com/news/moonlake-sonelokimab-vela-study-results-hidradenitis-suppurativa/761322/