Press release
MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa
MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and
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[{"type":"text","content":"MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa (HS) Maintenance treatment with sonelokimab dosed every 4 weeks (Q4W), demonstrated that 57% of patients achieved HiSCR75 at week 24, increasing the landmark week 12 responses (primary endpoint) by over 10 ppt (percentage points)The depth of responses continued to increase from week 12 to week 24 across several scores, including over 14 ppt increases in HiSCR90 and IHS4-90 (to approximately 40% of patients) – 1 in every 4 patients reached inflammatory remission with IHS4-100, reflecting 100% reduction in abscesses, nodules and draining tunnelsRates of complete resolution of inflammatory nodules and abscesses (AN 100) and draining tunnels (DT 100) increased between week 12 and 24Clinical responses translated to robust improvements in health related quality of life (DLQI), skin pain (NRS30), and self-reported absent or minimal disease (PGI-S)Maintenance dosing, placebo cross-overs to sonelokimab 120mg or 240mg, as well as pharmacokinetic data, confirm 120mg as the dose with optimal benefit-risk profileFor non-responders to adalimumab at week 12 switching to sonelokimab resulted in HiSCR75 response rates similar to those randomized to sonelokimab at baselineSafety results of sonelokimab were consistent with previously reported studies with no new observed safety signalsTopline data will be discussed on 16 October, at 2pm CEST/ 8am EDT, via webcast (registration link below) ZUG, Switzerland, October 15 2023 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced positive 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 (HS). Jorge Santos da Silva, PhD, Founder and Chief Executive Officer at MoonLake, said: “The overall data package created with the MIRA trial establishes MoonLake’s position as a leading innovator in the Immunology and Inflammation (I&I) and IL-17 s...