MoonLake Immunotherapeutics shares plummet over 84% pre-market after releasing 16-week phase III trial results for Vela project evaluating nanobody Sonelokimab.

MoonLake Immunotherapeutics shares plummet over 84% pre-market after releasing 16-week phase III trial results for Vela project evaluating nanobody Sonelokimab.

MoonLake Immunotherapeutics (NASDAQ: MLTX) shares have plummeted by 84% in pre-market trading following the release of 16-week phase III trial results for its Vela project evaluating the nanobody Sonelokimab. The biotechnology company reported that while the trial met its primary endpoint of achieving a clinically meaningful and statistically significant improvement in hidradenitis suppurativa (HS) patients, the results were not as robust as expected, particularly in the VELA-2 trial.

The Vela program, comprising two identical trials (VELA-1 and VELA-2), aimed to evaluate the efficacy and safety of Sonelokimab in adult participants with moderate to severe HS. The primary endpoint was the HS Clinical Response (HiSCR) 75, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

The combined VELA program showed statistically significant improvements across all primary and key secondary endpoints using both pre-specified strategies (p0.001). However, the VELA-2 trial failed to achieve statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). This was due to intercurrent events in the higher-than-expected placebo arm.

Using the treatment policy strategy, which analyzes data irrespective of intercurrent events, both VELA-1 and VELA-2 achieved statistically significant HiSCR75 at week 16 with Sonelokimab (35% and 36%, respectively) vs placebo (18% and 26%, respectively). This strategy also showed clinically meaningful benefits for all key secondary endpoints.

Despite the mixed results, MoonLake continued to report a favorable safety profile for Sonelokimab, with no new safety signals detected. The company plans to seek regulatory approval for the drug and will hold a webcast on September 29 to discuss the trial results further.

The stock's pre-market drop can be attributed to the unexpected placebo response rate in VELA-2, which was higher than anticipated. Investors may be reassessing the potential market demand and clinical efficacy of Sonelokimab based on these results.