Soterios’ alopecia areata drug hits main goal in mid-stage study

30 May 2024
firstwordpharma.com
Clinical ResultDrug ApprovalPhase 2
Soterios Pharma announced Thursday that its investigational topical hair-loss therapy STS-01 met the primary and key secondary endpoints of a Phase II study of patients with alopecia areata.
According to the company, STS-01 functions by disrupting signalling pathways to modulate the inflammatory response and T-cell proliferation.
The mid-stage study enrolled 158 patients with mild or moderate alopecia areata, who were randomised to receive either one of four doses of STS-01 (0.25%, 0.5%, 1% or 2%) or placebo for 24 weeks. The primary endpoint was >30% improvement on the Severity of Alopecia Tool (SALT) score, while secondary endpoints included total hair regrowth with the 1% and 2% doses of STS-01.
Topline results showed that after 24 weeks, 75.9% of participants treated with 1% STS-01 achieved the main goal, compared with 36.7% of placebo recipients. Moreover, 19% and 27% of participants on 1% and 2% STS-01, respectively, achieved total hair regrowth (SALT 0) compared with 3% of those on placebo.
The company said the drug was well tolerated, with no major adverse events. Detailed findings will be presented at a forthcoming medical conference. "This data gives us clarity and confidence in moving into late-stage clinical development for this product,” said CEO David Fleet.
While systemic JAK inhibitorsJAK inhibitors such as Eli Lilly and Incyte’s Olumiant (baricitinib) and Pfizer’s Litfulo (ritlecitinib) have been approved in the US for severe alopecia areata, there remains an unmet treatment need for individuals with mild or moderate disease, who account for more than half of the 800,000 patients with the condition in the US, Soterios said.
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