MoonLake’s Sonelokimab Faces Disastrous Phase 3 Trial Results in Autoimmune Drug Development

Moonlake Immunotherapeutics’ management team faced a harsh reality this past Sunday as the results from its twin Phase 3 studies in hidradenitis suppurativa (HS), an autoimmune skin condition, were unequivocal failures. Despite initial optimism, the data revealed that sonelokimab, the company’s sole drug candidate, could not deliver the expected therapeutic benefits necessary for market viability.

Following the announcement, Moonlake’s stock price plummeted, reflecting investor concerns about the future of sonelokimab. While the first study showed a statistically significant improvement over placebo by 17 percentage points in HS disease response, the margin was insufficient to position sonelokimab as a competitive option against Bimzelx, a similar antibody from UCB that currently dominates the market. This outcome raises critical questions about Moonlake’s strategic direction and the potential ramifications for its stakeholders as they navigate a challenging landscape in autoimmune therapeutics.