MoonLake Reports Positive 52-Week Phase 3 Data for Sonelokimab in Hidradenitis Suppurativa

MoonLake Immunotherapeutics has announced positive 52-week results from its phase 3 VELA-1 (NCT06411899) and VELA-2 clinical trials evaluating investigational sonelokimab (SLK) in adults with moderate-to-severe hidradenitis suppurativa (HS), reporting durable efficacy, sustained improvements in patient-reported outcomes, and no new safety signals through 1 year.¹

The update builds on previously reported phase 3 findings showing statistically significant improvements in the primary HiSCR75 end point at week 16 and follows recent FDA feedback supporting MoonLake's planned Biologics License Application strategy for sonelokimab in HS.²⁴

52-Week Results Demonstrate Durable Responses

Across both phase 3 trials, 67.2% of patients receiving sonelokimab achieved Hidradenitis Suppurativa Clinical Response (HiSCR)75 at week 52, while 33.1% achieved HiSCR100. Additionally, 26% of participants reached IHS4-100, indicating complete inflammatory remission. The findings build upon previously reported week 16 results and demonstrate continued improvement over time.¹

The company also reported sustained benefits across multiple patient-reported outcomes. Patients experienced an average 15-point reduction in Hidradenitis Suppurativa Quality of Life (HiSQOL) scores from baseline, corresponding to an improvement from severe to mild quality-of-life impairment. Nearly half (46.5%) also achieved at least a 3-point reduction in worst skin pain on the Numerical Rating Scale.¹

No new safety signals were observed through week 52, and approximately 90% of patients enrolled in the program transitioned into the ongoing open-label extension study, supporting the long-term tolerability of the once-every-4-week dosing regimen.

MoonLake also shared interim week 24 findings from the phase 3 VELA-TEEN study, which is evaluating sonelokimab in adolescents aged 12 to 17 years with moderate to severe HS. Approximately 68% of participants achieved HiSCR75, 86% achieved HiSCR50, and nearly 45% reached HiSCR100. No new safety concerns were identified in the adolescent population.

"The final week 52 data from the VELA program confirm the strength of SLK across most, if not all, metrics that matter in HS: strong early efficacy, sustained and leading improvement over time, a consistent safety profile and great convenience in dosing," said Jorge Santos da Silva, founder and chief executive officer of MoonLake Immunotherapeutics.¹

Quality of Life and Pain Outcomes Improve

Kristian Reich, MD, PhD, founder and chief scientific officer of MoonLake, emphasized the importance of patient-reported outcomes alongside clinical responses.

"The sustained improvements we observed across HiSQOL, pain and broader quality-of-life measures are highly meaningful in HS, where the burden of disease extends far beyond lesion counts," Reich said in the release.¹

MoonLake stated it plans to submit a Biologics License Application to the FDA by the end of September 2026. The company also intends to request Priority Review based on sonelokimab's clinical profile and inclusion of adolescent data, although the FDA has not yet determined whether Priority Review will be granted. If accepted under standard review, the company anticipates a potential US launch in the second half of 2027.³

References

1. MoonLake announces week 52 results of sonelokimab from its phase 3 VELA program in hidradenitis suppurativa and confirms investor day on June 22, 2026. News release. MoonLake Immunotherapeutics. June 21, 2026. Accessed July 1, 2026. https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-announces-week-52-results-sonelokimab-its-phase-3-vela
2. Hebebrand M. MoonLake shares findings from dual phase 3 trials of sonelokimab. Dermatology Times. October 1, 2025. Accessed July 1, 2026. https://www.dermatologytimes.com/view/moonlake-shares-findings-from-dual-phase-3-trials-of-sonelokimab
3. Hebebrand M. FDA feedback supports BLA pathway for sonelokimab in HS. Dermatology Times. January 8, 2026. Accessed July 1, 2026. https://www.dermatologytimes.com/view/fda-feedback-supports-bla-pathway-for-sonelokimab-in-hs
4. Hebebrand M. Sonelokimab demonstrates high HiSCR100 rates and durable responses in hidradenitis suppurativa. Dermatology Times. Published March 2026. Accessed July 1, 2026. https://www.dermatologytimes.com/view/sonelokimab-demonstrates-high-hiscr100-rates-and-durable-responses-in-hidradenitis-suppurativa