Moonlake Immunotherapeutics Achieves Significant Milestone With Positive Phase 2 Results for Nanobody® Sonelokimab in Hidradenitis Suppurativa
Monday, June 26, 2023
MoonLake Immunotherapeutics ("MoonLake"; Nasdaq: MLTX) has released positive top-line results from its global Phase 2 MIRA trial, which assessed the efficacy and safety of their Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). This trial, known as M1095-HS-201, is the first of its kind to utilize the Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as the primary endpoint, offering a more comprehensive measure of clinical response compared to previous trials. The results mark a significant milestone in the development of HS treatments.
The trial successfully met its primary endpoint, with a significantly higher proportion of patients receiving sonelokimab at both 120mg and 240mg doses achieving HiSCR75 compared to those receiving placebo after 12 weeks. The primary analysis utilized the intent-to-treat non-responder imputation (ITT-NRI) method, the most rigorous analysis for such trials. Both doses exhibited similar performance, with the 120mg dose showing the greatest improvement in HiSCR75 and HiSCR50. The 120mg dose demonstrated a 29 percentage point difference from placebo on HiSCR75 (p=0.0002) and a 38 percentage point difference on HiSCR50 (p<0.0001). These results indicate that the Nanobody® sonelokimab, relative to placebo, shows the highest clinical activity among other therapies tested in similarly stringent pivotal trials as early as week 12.
Furthermore, the trial's secondary endpoints, including HiSCR90, improvements in the International Hidradenitis Suppurativa Severity Score System (IHS) 4, reductions in abscess/nodule and draining tunnel counts, and patient-reported pain and quality of life outcomes, also exhibited statistically significant improvements at week 12. The 120mg dose of Nanobody® sonelokimab, previously identified as optimal in psoriasis treatment, showcased favorable performance, highlighting the advantages of using a smaller biologic with albumin-binding capacity to inhibit IL-17A and IL-17F in managing inflammatory diseases.
The safety profile of sonelokimab remained consistent with previous studies, with no new safety concerns observed. Overall, sonelokimab continues to demonstrate a favorable safety profile in line with the known profile of IL-17 inhibitors.
Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, expressed satisfaction with the positive outcome of the Phase 2 MIRA trial. He emphasized that achieving their goal of surpassing the best results shown in pivotal trials of competitors demonstrates their commitment to improving patient outcomes. Dr. da Silva expressed confidence in MoonLake's future steps and their aspiration to become a leader in the inflammation and immunology field.
Kristian Reich, MD, PhD, Founder and Chief Scientific Officer at MoonLake, highlighted the groundbreaking nature of the positive results from the MIRA trial, indicating a new standard for the treatment of chronic inflammatory diseases. The smaller size of Nanobody® sonelokimab compared to traditional antibodies proved advantageous in diseases where optimal tissue penetration is crucial, such as hidradenitis suppurativa and potentially psoriatic arthritis. The data also validated sonelokimab's unique mode of action in efficiently inhibiting both IL-17A and IL-17F. Dr. Reich expressed gratitude towards the patients and investigators whose support and participation made the positive outcome of the MIRA trial possible.
