MoonLake announces full dataset from 24-week MIRA clinical trial

MoonLake Immunotherapeutics announced 24-week top-line results from its global Phase 2 MIRA trial showing that maintenance treatment with its Nanobody sonelokimab led to further improvements in HiSCR75 response rates and other clinically relevant outcomes in patients with moderate-to-severe hidradenitis suppurativa. The 24-week results follow the positive 12-week results, announced in June 2023 and subsequently presented at the European Academy of Dermatology and Venereology Congress in October 2023, in which the primary endpoint was met with 29 percentage points delta versus placebo at week 12. The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to use Hidradenitis Suppurative Clinical Response 75 as the primary endpoint. The 24-week results show that ongoing treatment with sonelokimab 120mg and 240mg dosed Q4W, further increased HiSCR75 response rates compared to week 12. 57% of patients continuously treated with 120mg achieved a HiSCR75 response and 38% achieved HiSCR90. The IHS4 score, which encompasses changes in all active HS lesions, decreased by 65% in patients treated with the 120mg maintenance dose. Rates of complete resolution of inflammatory nodules and abscesses together with complete resolution of draining tunnels also increased between week 12 and 24. Complete inflammatory remission was achieved in 1 in 4 patients treated with 120mg at week 24. Clinical responses translated to profound improvements in patient-reported outcomes at 24 weeks including quality of life, pain, and patient global impression of severity. 43% of patients reached self-reported absent or minimal disease activity on the PGI-S scale. Results obtained with placebo patients re-randomized to sonelokimab 120mg or 240mg in Part B, after the primary analysis, replicated the dose responses observed in Part A. Difficult-to-treat subgroup analysis confirms the advantage of the 120mg dose. Similarly, pharmacokinetics analysis support the use of the monthly maintenance 120mg dose. For patients who were inadequate responders to adalimumab at week 12 switching to sonelokimab resulted in HiSCR75 response rates similar to responses in those randomized to sonelokimab at baseline. Sonelokimab provided better durability of response compared to that observed with adalimumab in other studies. The safety profile of sonelokimab was consistent with previously reported studies with no new safety signals observed. Overall, sonelokimab continues to show a favorable safety profile, in line with the known profile of IL-17 inhibitors. Based on the efficacy and safety results, Q4W maintenance dosing of sonelokimab 120mg has been confirmed in the company’s view as the optimal dose, in terms of speed and depth of response, and overall benefit-risk profile, for progression into Phase 3 development.