MoonLake Immunotherapeutics Announces FDA, EMA Support of Furthering Phase 3 Sonelokimab for PsA

Image Credit: © DermNet

MoonLake Immunotherapeutics announced today that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have provided positive feedback on the company’s proposed phase 3 program for the Nanobody sonelokimab, intended for the treatment of psoriatic arthritis (PsA).¹

This regulatory approval follows promising regulatory feedback received earlier this year for MoonLake's phase 3 VELA program of sonelokimab in hidradenitis suppurativa. Recruitment for the VELA program is already underway.²

The phase 3 program for PsA, named IZAR, is designed to include 2 global, randomized, double-blind, placebo-controlled trials: IZAR-1 and IZAR-2. These trials will collectively enroll approximately 1,500 patients, supported by data from the phase 2 ARGO trial. The data from these trials will support both the Biologics License Application in the United States and the Marketing Authorization Application in the European Union.

The IZAR-1 trial will focus on biologic naïve patients, aiming to evaluate the radiographic progression of the disease. In this study, participants will be administered doses of 60mg and 120mg of sonelokimab to assess the medication's effectiveness in slowing or halting the progression visible on radiographic imaging.

The IZAR-2 trial will target patients who have an inadequate response to TNF inhibitors. A distinctive feature of this trial will be the inclusion of an active reference arm with risankizumab, providing a comparative benchmark for the efficacy of sonelokimab. Similar to the IZAR-1 trial, patients in IZAR-2 will receive either 60mg or 120mg doses of sonelokimab.

Both trials are designed to assess the efficacy and safety of sonelokimab over one year. The primary endpoint is the American College of Rheumatology 50 (ACR50) response rate at week 16 compared to placebo, with key secondary endpoints also measured at this time point. The first patient randomization for these trials is expected in quarter 4 of 2024, with the primary endpoint readout anticipated by the end of 2026.

Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, expressed his enthusiasm regarding the regulatory progress.

“The recent regulatory milestones for PsA mark the second such significant achievement for MoonLake, building on the positive FDA and EMA feedback for HS earlier this year," he said in the news release.¹ "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 underdiagnosed and underserved.”

References

1. MoonLake Immunotherapeutics announces positive regulatory feedback from both FDA and EMA on path for the phase 3 program for the Nanobody sonelokimab in psoriatic arthritis. News release. Globe Newswire. June 10, 2024. Accessed June 10, 2024. https://www.globenewswire.com/news-release/2024/06/10/2895960/0/en/MoonLake-Immunotherapeutics-Announces-Positive-Regulatory-Feedback-from-both-FDA-and-EMA-on-Path-for-the-Phase-3-Program-for-the-Nanobody-sonelokimab-in-Psoriatic-Arthritis.html
2. MoonLake Immunotherapeutics starts phase 3 VELA program of the nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa. News release. BioSpace. May 16, 2024. Accessed June 10, 2024. https://www.biospace.com/article/releases/moonlake-immunotherapeutics-starts-phase-3-vela-program-of-the-nanobody-sonelokimab-in-patients-with-moderate-to-severe-hidradenitis-suppurativa/