MoonLake Immunotherapeutics’s stock has crashed after its hidradenitis suppurativa (HS) candidate did not beat UCB’s Bimzelx (bimekizumab-bkz) in a pair of Phase III trials.
The VELA programme showed statistical significance across all endpoints; however, this was impacted by a higher-than-expected placebo response in the VELA-2 trial.
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In the VELA-1 trial (NCT06411899), 34.8% of patients receiving sonelokimab achieved HS Clinical Response (HiSCR) 75, the study’s primary endpoint, compared with 17.5% in the placebo arm after 16 weeks. The same endpoint was achieved in 35.9% of patients compared to 25.6% in the placebo cohort at the same time point in the VELA-2 trial (NCT06411379).
In both trials, there was no notable change in response rate between 12 weeks and 16 weeks, signalling that the response may not improve with lengthened use. Despite the data, MoonLake states that preliminary analysis suggests that responses continue to improve beyond week 16.
Meanwhile, in a Phase III programme, HiSCR75 was achieved by 64% of patients who received Bimzelx after 96 weeks.
HiSCR 75 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.
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By GlobalDataSecondary endpoints in the VELA programme were also met, including HiSCR50, International HS Severity Scoring System (IHS4-55), and patient-reported outcomes of Pain Numeric Rating Scale (NRS), HS-specific Quality of Life score (HiSQOL) and Dermatology Quality of Life Index (DLQI).
The company’s stock dropped 88.77% on the news, from a 26 September close of $61.99 to a 29 September open of $6.96.
GlobalData neurology and immunology director Erela Dana said: “The expectation was that sonelokimab would outperform Bimzelx, which showed HiSCR75 in ~60% of patients in Phase III studies.
“However, the 16-week data shows that not only has the benefit remained stagnant at ~35% mark after 12 weeks in the combined arm, in the VELA-2 trial, it decreased. This is combined with very high placebo rates. Durability of effect over 24+ weeks was defined as the primary driver of who could become the new blockbuster/leader in HS by KOLs, so the results are disappointing.”
GlobalData is the parent company of Clinical Trials Arena.
The safety profile of sonelokimab, an IL-17 inhibitor, was consistent with previous studies, with no new safety signals observed.
Despite the data not being as strong as expected, MoonLake will still speak with regulators, including providing data on the higher-than-expected placebo response rate in VELA-2 at week 16, to guide a path to submission of a biologics licence application (BLA) in the US.
According to GlobalData, the HS market is forecast to grow from $1.84bn in 2024 to $7.83bn in 2034.
In July 2025, Novartis culled its HS candidate ianalumab after a Phase IIb proof of concept trial failed to meet its primary endpoint.
