Shares of MoonLake Immunotherapeutics (NASDAQ: MLTX) are surging by 89.93% in early-hours trading on Monday. The surge follows the release of promising results from the Phase 2 MIRA trial evaluating the Nanobody sonelokimab as a potential treatment for patients with moderate-to-severe hidradenitis suppurativa (HS).
Hidradenitis suppurativa (HS) is a painful, chronic skin condition that causes abscesses and scarring.
The MIRA trial is the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint, representing a milestone in HS clinical development.
The results of the trial showed that both the 120mg and 240mg doses of sonelokimab achieved notably higher HiSCR75 response rates compared to the placebo after 12 weeks.
Furthermore, both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg dose achieved a 29 ppt delta to placebo on HiSCR75 (p=0.0002) and a 38ppt delta to placebo on HiSCR50 (p<0.0001)
Other secondary endpoints, such as HiSCR90, improvements in International Hidradenitis Suppurativa Severity Score System (IHS) 4, abscess/nodule and draining tunnel counts, patient-reported pain, and quality of life outcomes, also reached statistical significance at week 12.
MoonLake’s CEO expressed utmost confidence in the positive outcome of the trial, reinforcing the company’s aspiration to become a leader in the field of inflammation and immunology.
The MIRA trial will continue for a total of 24 weeks, with an additional 4-week safety follow-up period. This extended timeline aims to collect more comprehensive data on the long-term efficacy and safety of sonelokimab.
Sonelokimab has shown promise in a Phase 2b trial for plaque-type psoriasis, and it is currently being evaluated in a Phase 2 trial for psoriatic arthritis.
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