MoonLake Immunotherapeutics disclosed the Week 40 results of its Phase 3 VELA‑1 and VELA‑2 trials for sonelokimab on March 28, 2026, during the American Academy of Dermatology Annual Meeting in Denver. The company reported that 62 % of patients treated with sonelokimab achieved the primary endpoint of a 75 % reduction in inflammatory lesions (HiSCR75) and 32 % reached complete lesion control (HiSCR100).
The Week 40 data address concerns raised by the earlier VELA‑2 Week 16 analysis, which had a higher-than‑expected placebo response and did not meet its primary endpoint. The sustained efficacy seen at Week 40 demonstrates that sonelokimab’s therapeutic effect continues to build over time, providing reassurance that the drug’s benefit profile is durable and not a transient phenomenon.
Efficacy metrics also include a 77 % response rate for a 55 % reduction in the International HS Severity Scoring System (IHS‑4 55) and 25 % of patients achieving inflammatory remission (defined as A100 + DT100 + N100). These rates exceed the HiSCR75 outcomes of currently approved IL‑17 inhibitors, which hover around 40 % to 60 % at one year, positioning sonelokimab as a potentially superior option for moderate‑to‑severe hidradenitis suppurativa.
Safety data remain consistent with earlier interim analyses, and discontinuation rates are low, indicating that the drug is well tolerated over the long term. The company plans to submit a Biologics License Application to the FDA in the coming months, a step that could accelerate regulatory review and market entry if the data are accepted.
From a business perspective, the results strengthen MoonLake’s competitive positioning in a market with significant unmet need. The company’s $394 million cash balance provides a runway into the second half of 2027, allowing continued investment in clinical development while preparing for regulatory submission. The positive data also support the company’s Fast Track designation for sonelokimab in palmoplantar pustulosis, underscoring its broader therapeutic potential.
Analysts have responded favorably to the Week 40 results, upgrading the company’s outlook and highlighting the drug’s strong efficacy and safety profile as key drivers of future growth. The data are expected to reinforce investor confidence in MoonLake’s pipeline and its strategy to address a high‑need patient population.
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