MoonLake's Sonelokimab Achieves Exceptional 52-Week Phase 3 Efficacy in Hidradenitis Suppurativa

MoonLake's Sonelokimab Achieves Exceptional 52-Week Phase 3 Efficacy in Hidradenitis Suppurativa

On June 21, 2026, MoonLake Immunotherapeutics announced highly positive, final 52-week (1-year) results from its dual Phase 3 clinical trials, VELA-1 and VELA-2, evaluating its investigational anti-IL-17A/F nanobody, sonelokimab (SLK), in adults with moderate-to-severe hidradenitis suppurativa (HS).

The 1-year results demonstrate exceptionally deep, durable, and progressive clinical efficacy, reinforcing sonelokimab's potential as a best-in-class biologic for this painful, chronic inflammatory skin condition.

Deep and Durable 1-Year Clinical Efficacy

The VELA program evaluated subcutaneous sonelokimab dosed once every four weeks.¹ The 52-week data showed substantial improvements compared to previously reported 16-week outcomes, demonstrating that therapeutic benefit continues to deepen over time:

• HiSCR75: 67.2% of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) 75 (a $\ge 75%$ reduction in total abscess and inflammatory nodule count with no increase in abscesses or draining fistulas).
• HiSCR100: 33.1% of patients achieved a complete HiSCR100 response (100% clearance of inflammatory lesions).
• Complete Remission (IHS4-100): 26% of patients achieved a complete inflammatory remission, defined by the International Hidradenitis Suppurativa Severity Score System (IHS4).

Profound Impact on Pain and Quality of Life

Because HS is a physically debilitating and emotionally exhausting disease, patient-reported outcomes (PROs) are highly critical metrics:

• Quality of Life Improvement: Patients experienced a mean 15-point reduction in Hidradenitis Suppurativa Quality of Life (HiSQOL) scores, shifting on average from "severe" to "mild" quality-of-life impairment.
• Skin Pain Reduction: 46.5% of patients achieved a clinically meaningful $\ge 3$-point reduction in worst skin pain on the Numerical Rating Scale (NRS).

VELA-TEEN Adolescent Interim Efficacy

MoonLake also shared highly encouraging interim 24-week data from its Phase 3 VELA-TEEN study evaluating sonelokimab in adolescents aged 12 to 17 years with moderate-to-severe HS:

• HiSCR50: 86% of adolescent patients achieved HiSCR50.
• HiSCR75: 68% achieved HiSCR75.
• HiSCR100: ~45% achieved HiSCR100.
• No new safety concerns were identified in the adolescent population.

Safety and Tolerability

Sonelokimab demonstrated a highly favorable safety and tolerability profile through 52 weeks, with no new safety signals observed. The robustness of the safety profile is underscored by the fact that approximately 90% of patients completing the VELA trials chose to transition into the ongoing open-label extension study.

Regulatory Strategy and Launch Plans

Following recent positive feedback from the FDA, MoonLake plans to formally submit its Biologics License Application (BLA) for sonelokimab in HS by the end of September 2026. The company intends to request Priority Review based on its strong clinical package and the inclusion of adolescent data. If granted a standard review, MoonLake anticipates a potential U.S. commercial launch in the second half of 2027.

"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 time², a consistent safety profile and great convenience in dosing." — Jorge Santos da Silva, Founder and CEO of MoonLake Immunotherapeutics