MoonLake hit by placebo effect in Phase III study, stock plunges

Swiss biotech MoonLake Immunotherapeutics (Nasdaq: MLTX) has released top-line data from two Phase III trials of its inflammatory disease candidate sonelokimab in hidradenitis suppurativa, with mixed outcomes that left investors rattled.

The 838-patient program tested the interleukin (IL)-17 inhibitor against placebo at 16 weeks. Both VELA-1 and VELA-2 met statistical significance on secondary measures such as pain, lesion reduction and quality-of-life scores, and safety was in line with earlier studies. However, VELA-2’s unexpectedly strong placebo effect meant the trial narrowly missed its primary goal, even though VELA-1 delivered the expected response.

“We are encouraged by the results of VELA-1…The higher-than-expected placebo response rate in VELA-2 is disappointing but we are encouraged by the consistent performance of sonelokimab arms across all endpoints in both studies,” said chief scientific officer Kristian Reich.