Soterios Pharma Reports Positive Phase II Results for STS-01 in Treating Alopecia Areata

Soterios Pharma has unveiled promising results from a Phase II trial of their topical treatment STS-01 for mild to moderate alopecia areata (AA). The trial, which was randomised, placebo-controlled, and multi-dose, demonstrated significant efficacy and safety of the treatment. This advancement marks a potential breakthrough for over half of the estimated 800,000 AA patients in the United States who currently lack approved therapies.

The trial results, announced on May 30, 2024, showed that 75.9% of participants treated with a once-daily topical application of 1% STS-01 achieved more than a 30% improvement in their Severity of Alopecia Tool (SALT) score after 24 weeks. In contrast, only 36.7% of patients receiving a placebo reached this level of improvement. These results were statistically significant, with a p-value of less than 0.0096.

Additionally, the trial met several secondary endpoints, revealing substantial hair regrowth in both the 1% and 2% STS-01 dose groups. Specifically, 19% and 27% of patients in these groups achieved total hair regrowth (SALT score of 0), compared to only 3% in the placebo group. The data indicated a clear dose-response relationship, further validating the treatment's efficacy.

Importantly, STS-01 was well tolerated among patients, with no reported major adverse events. The safety profile of STS-01 is grounded in its mechanism, which modulates the inflammatory response and T-cell proliferation by disrupting specific signalling pathways. This makes it a promising candidate for long-term use in managing AA.

Dr. Arash Mostaghimi, Associate Professor of Dermatology at Brigham & Women's Hospital, expressed optimism about the findings. He highlighted the potential for STS-01 to offer a safe and effective treatment option for individuals suffering from mild to moderate AA, a condition often accompanied by significant psychological distress such as depression and anxiety.

David Fleet, CEO of Soterios Pharma, also shared his enthusiasm for the trial outcomes. He emphasized the clarity and confidence these results provide for advancing STS-01 to late-stage clinical development. Fleet extended gratitude to all patients, investigators, and healthcare professionals involved in the study.

The Phase II trial assessed a total of 158 participants who were randomised to receive one of four STS-01 doses (0.25%, 0.5%, 1%, or 2%) or a placebo. The primary efficacy endpoint was an improvement in the SALT score after 24 weeks of treatment.

Soterios Pharma, based in the UK, is dedicated to developing and commercialising medicines for dermatological conditions with significant unmet needs. The company’s focus on STS-01 exemplifies its commitment to addressing the challenges faced by AA patients.

Full study results are expected to be presented at an upcoming medical conference, providing further insights into the potential of STS-01 as a standard-of-care treatment for mild to moderate AA. This development signals a hopeful future for patients who have long awaited effective and approved therapeutic options.