Positive new data for MoonLake's sonelokimab in HS

Swiss biotech firm MoonLake Immunotherapeutics (Nasdaq: MLTX) saw its US traded shares rise more than 5% to $57.55 pre-market, after it announced positive 24-week top-line results from its global Phase II 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).

MoonLake founder and chief executive Jorge Santos commented: “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 space. We have consistently observed best-in-class clinical activity with our Nanobody sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.”

He continued: “In June we elevated the bar for clinical response to HiSCR75 as the primary endpoint. We have now advanced to demonstrating even deeper responses (such as HiSCR90, AN 100 and DT 100) and on scores that are important for patients, such as complete inflammatory remission with IHS4-100 and absent or minimal disease activity as reported by patients (PGI-S). Importantly, the results have confirmed our view that 120mg is the optimal dose and we are on track to discuss our Phase II development plans with the FDA by the end of this year.”