MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

• VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint

• The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025

• Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in the United States and Europe, using a design informed by the landmark Phase 2 MIRA trial

Zug, Switzerland, May 16, 2024 – MoonLake Immunotherapeutics (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that the first patients have been screened at a U.S. trial site in its global Phase 3 clinical program, VELA, evaluating sonelokimab, an investigational Nanobody designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa (HS).

HS is a severely debilitating chronic skin condition, affecting up to 4.1% of the global population. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. Sonelokimab is designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues.

Following the positive results from the landmark Phase 2 MIRA trial, the Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2. Both trials are identical in design comparing a single 120mg dose of sonelokimab to placebo with the higher measure of clinical response, Hidradenitis Suppurativa Clinical Response (HiSCR) 75, as the primary endpoint reading out at week 16. 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. The Phase 3 program will use a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. The topline primary endpoint readout (week 16) from the VELA program is expected as of mid-2025.