MoonLake Immunotherapeutics has initiated its Phase 3 VELA program, a global clinical trial evaluating sonelokimab, an investigational Nanobody®, for patients with moderate-to-severe hidradenitis suppurativa (HS). The first patients have been screened at a U.S. trial site, marking a significant step in developing novel treatment options for this debilitating condition. The topline primary endpoint readout at week 16, along with data on other endpoints, is expected as of mid-2025.
The VELA program includes two identical trials, VELA-1 and VELA-2, designed to enroll 800 patients across sites in the United States and Europe. These trials will compare a 120mg dose of sonelokimab to placebo, with the primary endpoint being the Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at week 16. This higher clinical response level aims to set a new standard in HS treatment.
Trial Design and Endpoints
The Phase 3 VELA program mirrors the design of the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. From week 16, all patients will receive the 120mg dose of sonelokimab through to 52 weeks, followed by an open-label extension for up to two years. Key secondary endpoints include HiSCR50, change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), Dermatology Life Quality Index (DLQI), Numerical Rating Scale (NRS50) in Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100).
Addressing Unmet Needs in HS Treatment
Hidradenitis suppurativa is a chronic inflammatory skin condition affecting up to 4.1% of the global population. It manifests as painful inflammatory lesions, typically around the armpits, groin, and buttocks, leading to irreversible tissue destruction and scarring if inadequately treated. With only two FDA-approved biologics currently available, there remains a significant unmet need for new treatment options that can provide inflammatory remission and address all patient types and lesions.
Sonelokimab: A Novel Approach
Sonelokimab is a ~40 kDa humanized Nanobody® designed to selectively bind to IL-17A and IL-17F, inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. This targeted approach aims to directly address sites of inflammation and penetrate difficult-to-reach inflamed tissues. Its unique mode of action, effectively inhibiting IL-17F in addition to IL-17A in deep tissue inflammation, has shown promising outcomes in earlier trials.
Expert Perspectives
Kristian Reich, Founder and Chief Scientific Officer at MoonLake, emphasized the significance of using HiSCR75 as the primary endpoint, stating, "The launch of our Phase 3 VELA program with our Nanobody® sonelokimab, using the higher clinical measure of HiSCR75 as the primary endpoint and a straightforward, proven study design is a landmark moment in our efforts to develop novel treatment options for patients suffering with this under-diagnosed and under-treated condition."
Hadar Lev-Tov, MD, MAS, Associate Professor at the University of Miami, highlighted the urgent need for new treatment options, noting, "With only two FDA approved biologics, there is still an urgent need for new treatment options that treat all patient types and lesions, with the opportunity for inflammatory remission."
Financial Position and Future Outlook
MoonLake Immunotherapeutics reported a strong financial position with $511.0 million in cash, cash equivalents, and short-term marketable debt securities as of December 31, 2023. This is expected to support the clinical development of sonelokimab across multiple indications, providing a cash runway to the end of 2026.
