Hidradenitis Suppurativa Treated with Sonelokimab Shows Significant Improvement

MoonLake Immunotherapeutics recently announced positive results from its global Phase 2 MIRA trial examining the safety and efficacy of using Nanobody sonelokimab to treat patients with moderate to severe hidradenitis suppurativa (HS).¹ The MIRA trial was the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint.

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The trial recruited 234 patients with moderate to severe HS. Participants were treated with either 120 mg sonelokimab, 240 mg sonelokimab, or a placebo.

As early as week 12, a greater number of participants on both doses of sonelokimab achieved HiSCR75 compared with those on a placebo. The highest delta on HiSCR75 and HiSCR50 was achieved on the 120 mg dose, achieving a 29 ppt delta to placebo on HiSCR75 (p=0.0002) and a 38 ppt delta to placebo on HiSCR50 (p<0.0001).

Other clinically relevant secondary endpoints also showed statistical significance at week 12, including HiSCR90, improvements in International Hidradenitis Suppurativa Severity Score System (IHS) 4, and abscess/nodule and draining tunnel counts. In addition, patients reported improvements in pain and quality of life outcomes.

Alexa B. Kimball, MD, MPH, lead investigator of the MIRA trial, investigator at Beth Israel Deaconess Medical Center, Massachusetts, and professor of dermatology at Harvard Medical School said, “Hidradenitis suppurativa is a chronic, inflammatory, recurrent, and debilitating skin disease that has profound and wide-ranging impacts across many aspects of patient’s lives. As a physician, I see tremendous need for new treatment options for people living with HS, particularly for treatments to reach high thresholds of response in clinical trials (e.g., HiSCR75 and beyond). The positive high clinical responses observed with sonelokimab in the Phase 2 MIRA trial are encouraging, demonstrating its promise as a potential future treatment option.”

The positive results at the lower 120 mg dose display the advantage of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F to treat inflammatory diseases. No new safety signals were observed with sonelokimab at the 120 mg and 240 mg doses.

Reference

1. MoonLake Immunotherapeutics achieves landmark milestone with positive Phase 2 results for Nanobody® sonelokimab in hidradenitis suppurativa. MoonLake Immunotherapeutics AG. News Release. June 25, 2023. Accessed June 30, 2023. https://www.globenewswire.com/news-release/2023/06/25/2694014/0/en/MoonLake-Immunotherapeutics-achieves-landmark-milestone-with-positive-Phase-2-results-for-Nanobody-sonelokimab-in-hidradenitis-suppurativa.html