MoonLake Immunotherapeutics (NASDAQ: MLTX) has made significant strides with the successful outcome of their Phase 2 MIRA trial for sonelokimab, setting new benchmarks for the treatment of hidradenitis suppurativa (HS).
MoonLake Achieves Landmark in HS Clinical Development
MoonLake’s global Phase 2 MIRA trial has set an unprecedented milestone in the HS clinical development landscape. The trial, which involved 234 patients, is the first of its kind to report positive top-line results using the Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint. This stands as a higher measure of clinical response compared to the HiSCR50 measure employed in other clinical trials.
Positive Outcomes with Sonelokimab Highlighted by Clinically Relevant Secondary Endpoints
The trial exhibited a higher proportion of patients achieving HiSCR75 with both the 120mg and 240mg doses of sonelokimab when compared to those on placebo at the 12-week mark. Notably, the 120mg dose had the highest delta on HiSCR75 and HiSCR50, with 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 such as HiSCR90, International Hidradenitis Suppurativa Severity Score System (IHS4), abscess/nodule, draining tunnel counts, and patient-reported pain and quality of life outcomes, also met statistical significance at the 12-week period.
The Unrivalled Safety Profile of Sonelokimab
The safety profile of sonelokimab remained consistent with previous studies, revealing no new safety concerns. It continues to exhibit a favorable safety record, aligning with the known profile of IL-17 inhibitors.
MoonLake’s Aspirations for the Future
Jorge Santos da Silva, the CEO of MoonLake, expresses greater confidence in their ambitious goals after the successful outcome of the Phase 2 MIRA trial. MoonLake aims to raise the bar for HS treatment and establish itself as a leader in the inflammation and immunology space.
The Future of Sonelokimab in Treating Inflammatory Diseases
Sonelokimab demonstrates great promise as a future treatment option. It is currently being evaluated in a Phase 2 trial (ARGO) in patients with active psoriatic arthritis. A comprehensive understanding of its long-term efficacy and safety profile will be achieved with further data collection from the MIRA trial and the adalimumab arms.
MoonLake’s Continued Commitment to Patient Welfare
MoonLake’s dedication to elevating patient outcomes is evident from their pioneering efforts in developing next-level therapies for inflammatory diseases. Their commitment remains steadfast as they aim to meet and beat the best results from pivotal-like trials of competitors.
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