MoonLake Immunotherapeutics‘ (NASDAQ: MLTX) stock price fell off a cliff Monday after it reported week-16 results from its Phase 3 VELA-1 and VELA-2 trials.
The trials used HiSCR75—a 75% reduction in abscess and inflammatory nodule count with no increase in abscesses or draining tunnels—as the primary endpoint.
Key secondary endpoints included HiSCR50 response rates and improvements in Dermatology Quality of Life Index (DLQI) scores, reflecting patient, physician, and regulatory priorities.
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A total of 838 patients were enrolled across both trials.
The trials were identical in design, comparing a single 120mg dose of sonelokimab to placebo, with HiSCR75 reading out at week 16. From week 16, all patients receive the 120mg dose of sonelokimab through to week 48, with a final assessment at week 52, followed by an open-label extension for up to two years.
In the combined Phase 3 VELA program, all endpoints reached statistical significance with p-values below 0.001, including lesion counts and patient-reported outcomes (PROs).
Sonelokimab demonstrated the expected response profile over time, with statistically significant HiSCR75 achieved in both studies as early as week 4.
A preliminary analysis suggests that responses continue to improve beyond week 16 and that placebo patients crossing over at week 16 achieve similar responses to those randomized initially to the sonelokimab 120mg arm, as of week 20.
Using the treatment policy strategy as per protocol, both VELA-1 and VELA-2 demonstrated a statistically significant increase in the percentage of participants achieving HiSCR75 at week 16, providing a clinically meaningful benefit.
Response rates for sonelokimab 120mg were consistent between the two trials, with 34.8% and 35.9% of patients in VELA-1 and VELA-2 achieving HiSCR75 at week 16, respectively.
The placebo response rate in VELA-1 of 17.5% at week 16 was within the historical Phase 3 range of 13% to 18%. The placebo response rate in VELA-2 of 25.6% at week 16 was higher than expected.
VELA-1 and VELA-2 achieved statistical significance for all key secondary endpoints, including other lesion count-based endpoints (HiSCR50 and IHS4-55) and relevant PROs in hidradenitis suppurativa (HS).
Around 30% of patients experienced a marked reduction in pain, as measured by an improvement of at least 3 points in the worst pain NRS, in both VELA-1 and VELA-2.
Sonelokimab significantly improved the HiSQOL score at week 16, consistent between VELA-1 and VELA-2.
Almost 60% of patients achieved a meaningful (4 points or more) improvement of DLQI, an approximately 20 percentage-point benefit over.
"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…We are pleased to see a favorable safety profile consistent with previous studies, with no new safety signals," Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented.
Price Action: MLTX stock is down over 90% at $6.18 as of the last check on Monday.
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