MoonLake’s Phase 3 trials for autoimmune skin condition miss mark

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

MoonLake Immunotherapeutics’ management team could not stop spinning Sunday, even when the results reported from its twin Phase 3 studies in hidradenitis suppurativa, an autoimmune skin condition, were unequivocal failures. 

Investors were not buying it. MoonLake’s stock price was plunging Monday as the future dims for sonelokimab, the biotech company’s only drug candidate.

In the first MoonLake study, sonelokimab beat placebo on a measure of hidradenitis suppurativa, or HS, disease response by 17 percentage points. The difference was statistically significant, so technically, the study was a win. However, the improvement margin for sonelokimab fell well short of what was required for the drug to be commercially competitive against Bimzelx, a similar antibody from UCB that is approved and the current standard of care. 

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