Soterios: Topical STS-01 Achieves Phase 2 Efficacy Endpoints for Mild to Moderate Alopecia

by Barbara

A new phase 2 trial from Soterios Pharma has revealed that the investigational therapy STS-01 1% is associated with a significant improvement in patients with alopecia areata. Over a 24-week period, more than double the rate of patients using STS-01 achieved a ≥30% improvement in the Severity of Alopecia Tool (SALT) score compared to those receiving a placebo.

STS-01, a non-steroidal topical cream targeting cytokines, met its primary efficacy endpoint by demonstrating significant hair regrowth without major adverse events. These promising findings support the therapy’s advancement to late-stage clinical trials.

The UK-based company emphasized that STS-01 has been “modified to maximize the efficacy of this mechanism and offer a cosmetically elegant topical cream.” This positions STS-01 as a potential alternative to JAK inhibitors, which, while effective, are often limited by their side effects and high costs.

The phase 2 trial was randomized, placebo-controlled, and multi-dose, involving 158 participants with mild to moderate alopecia areata. The participants were divided into groups receiving daily doses of 0.25%, 1%, or 2% STS-01, or a placebo. The primary measure of efficacy was the improvement in the SALT score.

Results showed that 75.9% of patients using the 1% STS-01 cream achieved the primary efficacy endpoint of SALT 30 by 24 weeks, compared to 36.7% of those on placebo (P <.0096). Furthermore, total hair regrowth (SALT 0) was achieved by 19% of patients on the 1% STS-01 cream and 27% on the 2% cream, versus only 3% of the placebo group.

Importantly, the treatment was well-tolerated, with no major adverse events reported. Soterios suggests that STS-01 has the potential to become the first regulated therapy for patients with mild to moderate alopecia areata, affecting over 400,000 individuals in the US alone.

“These results are extremely encouraging,” stated Dr. Arash Mostaghimi, associate professor of dermatology at Brigham & Women’s Hospital. “They validate the potential for STS-01 to provide mild-to-moderate alopecia sufferers with a safe and effective treatment for this debilitating condition. I am also excited by the prospect of targeting total hair regrowth in this patient group.”

David Fleet, CEO of Soterios, expressed confidence in the progression of STS-01 towards a US Food and Drug Administration (FDA) application. “This data gives us clarity and confidence in moving into late-stage clinical development for this product,” Fleet said. “We thank all the patients, investigators, and healthcare staff who participated in this study.”

With these promising phase 2 results, STS-01 is poised to offer a new, effective treatment option for those suffering from mild to moderate alopecia areata.

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