Soterios' alopecia drug succeeds in mid-stage trial

Soterios Pharma announced on Thursday that its experimental topical treatment for hair loss, STS-01, successfully met both the primary and key secondary endpoints in a Phase II clinical trial involving patients with alopecia areata. Alopecia areata is an autoimmune condition characterized by patchy hair loss on the scalp and other areas of the body.

STS-01 works by interfering with signaling pathways to regulate the inflammatory response and T-cell proliferation, the company explained. The mid-stage clinical trial included 158 patients who had mild to moderate alopecia areata. These participants were randomly assigned to receive one of four dosages of STS-01 (0.25%, 0.5%, 1%, or 2%) or a placebo over a 24-week period.

The trial’s primary endpoint was defined as achieving over a 30% improvement in the Severity of Alopecia Tool (SALT) score. Secondary endpoints included total hair regrowth, particularly with the 1% and 2% dosages of STS-01.

Topline results from the study showed that 75.9% of patients treated with the 1% dose of STS-01 achieved the primary endpoint, compared to 36.7% of those who received the placebo. Additionally, total hair regrowth (SALT 0) was observed in 19% and 27% of participants on the 1% and 2% doses of STS-01, respectively, as opposed to just 3% in the placebo group.

Soterios Pharma noted that the treatment was well tolerated by patients, with no significant adverse events reported. More detailed findings are scheduled to be presented at an upcoming medical conference.

David Fleet, CEO of Soterios Pharma, commented on the trial results, stating, "This data gives us clarity and confidence in moving into late-stage clinical development for this product.”

While systemic JAK inhibitors like Eli Lilly and Incyte’s Olumiant (baricitinib) and Pfizer’s Litfulo (ritlecitinib) have been approved in the United States for treating severe alopecia areata, there is still a significant unmet need for treatments targeting mild to moderate cases of the condition. This demographic accounts for more than half of the 800,000 individuals diagnosed with alopecia areata in the U.S., Soterios Pharma highlighted.

The promising results of STS-01 offer hope for a new and effective topical treatment option for patients with mild to moderate forms of this challenging autoimmune disorder.

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