MoonLake Immunotherapeutics received positive feedback from the U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) on its Phase 3 Program for the nanobody sonelokimab in Psoriatic Arthritis (PsA).
Sonelokimab (M1095) is an investigational ~40 kDa humanized nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to interleukin (IL)-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers.
The Phase 3 program, named IZAR, is expected to enroll around 1,500 patients and in combination with data from the Phase 2 ARGO trial is designed to support both a Biologics License Application (BLA) and E.U. Marketing Authorization Application. Two global, randomized, double blind, placebo-controlled trials are planned (IZAR-1 and IZAR-2) to evaluate the efficacy and safety of the nanobody sonelokimab over one year. IZAR-1 will enroll a biologic naïve population and include an evaluation of radiographic progression, while IZAR-2 will enroll a tumor necrosis factor (TNF)-IR population and will be the first trial to include a risankizumab active reference arm. The IZAR program will assess a 60mg sonelokimab dose as well as a 120mg sonelokimab dose. The primary endpoint (ACR50) compared to placebo and key secondary endpoints for both trials will read out at week 16.
The readout of the primary endpoint is anticipated at the end of 2026.
“The recent regulatory milestones for PsA mark the second such significant achievement for MoonLake building on the positive FDA and EMA feedback for hidradenitis suppurativa earlier this year,” says Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, in a news release. “ These regulatory outcomes provide a clear roadmap for PsA and, by the end of 2024, we will have independently commenced three Phase 3 programs addressing two inflammatory indications that are under diagnosed and underserved. This progress is a testament to our specialized expertise and steadfast commitment to advancing the field of inflammation and immunology.”
