Soterios Announces New Positive Topline Results of STS-01 for Alopecia Areata

Ophiasic pattern alopecia areata | Image credit: DermNet

Soterios Pharma recently announced new positive topline results from its randomized, placebo-controlled, multi-dose, phase 2 clinical trial evaluating STS-01 for the treatment of mild to moderate alopecia areata. Key data points included at 24, weeks 75.9% of patients treated with a once-daily topical dose of STS-01 1% met the primary efficacy end point of achieving a >30% Severity of Alopecia Tool (SALT) score improvement compared to 36.7% of patients who received placebo (p<0.0096).¹

Regarding total hair regrowth (SALT 0) 19% and 27% of patients treated with STS-01 1% and 2%, respectively, achieved SALT 0 compared to 3% of patients who received placebo, with a clear dose response identified.

"These results are extremely encouraging. 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,” said Arash Mostaghini, MD, MPHD, FAAD, associate professor of dermatology at Brigham & Women's Hospital, in the news release.

Overall, STS-01 was well tolerated among patients with no reported major adverse events. According to Soterios, the company expects to present the complete study results at a future medical conference.

"This data gives us clarity and confidence in moving into late-stage clinical development for this product. We thank all the patients, investigators, and healthcare staff who participated in this study,” said David Fleet, chief executive officer of Soterios, in the news release.

Soterios’ phase 2 clinical trial of STS-01 included 158 patients who were randomized to receive one of 4 doses of STS-01, 0.25%, 0.5%, 1%, or 2%, or placebo, with efficacy measured based on the improvement in SALT scores.

According to Soterios, "STS-01 is being developed to address the need for an effective, safe, and convenient non-steroidal topical therapy for patients with mild-moderate (patchy) alopecia areata. The product builds on a mechanism with a well established safety profile in dermatology, and existing evidence of efficacy in this indication through targeting key relevant cytokines. STS-01 has been modified to maximise the efficacy of this mechanism, and offer a cosmetically elegant topical cream. Whilst the JAK inhibitors have the potential to offer a new treatment option for severe patients, their use more broadly will be limited by concerns with their side effect profiles (and price).”²

Related Alopecia Areata News

HRQoL of Patients with Alopecia Areata in Australia

Poster Presentations Demonstrate Efficacy of Deuruxolitinib in Patients With Moderate to Severe Alopecia Areata

Integrated Data From BRAVE-AA1 and BRAVE-AA2 Trials Supports Efficacy of Baricitinib Over 104 Weeks in Alopecia Areata

References

1. Soterios Pharma announces positive topline results from phase II study of STS-01 in the treatment of mild / moderate alopecia areata. News release. PR Newswire. May 30, 2024. Accessed May 30, 2024. https://www.prnewswire.com/news-releases/soterios-pharma-announces-positive-topline-results-from-phase-ii-study-of-sts-01-in-the-treatment-of-mild--moderate-alopecia-areata-302157892.html
2. Pipeline. Soterios Pharma. Accessed May 30, 2024. https://www.soteriospharma.com/#pipeline