MoonLake Immunotherapeutics announced promising results from the Phase 3 VELA-1 and VELA-2 trials for treating hidradenitis suppurativa with sonelokimab. Both trials showed statistically significant improvement in primary and key secondary endpoints, with a robust safety profile. The trials enrolled a total of 838 patients, and both achieved a clinically meaningful benefit at week 16. Sonelokimab demonstrated a favorable response over time, with responses continuing to improve beyond week 16. The company will seek regulatory approval based on these positive results and continue with other clinical studies to support their roadmap for treating inflammatory diseases. The VELA-1 and VELA-2 trials evaluated sonelokimab for moderate to severe hidradenitis suppurativa, with significant improvement in primary and secondary endpoints. Over 60% of patients saw a meaningful improvement in DLQI. The safety profile was consistent with previous studies. MoonLake is encouraged by the results and plans to discuss them with regulators for potential approval. Sonelokimab showed promise in HS treatment with convenient dosing. The Company is also progressing with sonelokimab development for other inflammatory diseases. A webcast will be held on September 29th. Sonelokimab is not yet approved for use. The VELA-1 and VELA-2 trials are evaluating the efficacy and safety of sonelokimab in adults with moderate to severe hidradenitis suppurativa (HS), using the HiSCR 75 as the primary endpoint. Data analysis showed a significant improvement in patients treated with sonelokimab. Sonelokimab is a humanized Nanobody® that selectively binds to IL-17A and IL-17F. The drug is being assessed in Phase 3 trials for HS and psoriatic arthritis, with positive results showing improvements in key outcomes. Additional trials are ongoing for other dermatological conditions. The VELA program has enrolled over 800 patients and uses multiple analysis strategies to ensure robust data. The VELA-1 and VELA-2 trials are evaluating the efficacy and safety of sonelokimab in adults with moderate to severe Hidradenitis Suppurativa (HS), using the HiSCR 75 as the primary endpoint. Patients treated with sonelokimab showed significant improvement in all primary and key secondary endpoints. Another trial, VELA-TEEN, will focus on pediatric patients with HS. HS is a chronic skin condition affecting about 2% of the population, with a market opportunity projected to reach $15bn by 2035. Sonelokimab targets IL-17A- and IL-17F-mediated inflammation in HS.

Sonelokimab is also being evaluated in the IZAR-1 and IZAR-2 trials for Psoriatic Arthritis, with primary endpoints of ACR 50 response at Week 16. PsA affects up to 30% of patients with psoriasis, leading to functional impairment. The S-OLARIS trial is investigating sonelokimab in patients with active axial Spondyloarthritis, aiming to reduce inflammation in the spine and joints. AxSpA typically impacts young individuals, leading to spinal fusion and mobility limitations. Sonelokimab is also being studied in the LEDA trial for Palmoplantar Pustulosis, a condition causing blister-like pustules on the palms and soles. Two Phase 3 trials, VELA-1 and VELA-2, are assessing sonelokimab for adult patients with moderate to severe hidradenitis suppurativa (HS) using a new primary endpoint, HS Clinical Response 75. Data from the VELA program showed significant improvements in all primary and key secondary endpoints with sonelokimab treatment. The IL-17 pathway is implicated in the pathophysiology of HS, highlighting the need for effective treatments. MoonLake’s forward-looking statements address trial design, enrollment, and potential market opportunities for sonelokimab, while acknowledging uncertainties in the clinical trial outcomes. Contact MoonLake for more information on their ongoing research and development programs.

Read more at VELA-1 and VELA-2 trials show promising results for sonelokimab in treating hidradenitis suppurativa in adults. Data analyzed using different strategies to ensure robustness of results. Patients treated with sonelokimab saw significant improvement in primary and secondary endpoints. (Source: GlobeNewswire): MoonLake Immunotherapeutics reports on week 16 results of