Soterios Pharma’s STS-01 performed well in mild to moderate alopecia areata, according to new Phase II data.
The trial included 158 participants who were randomized to receive one of four doses of STS-01 (0.25%, 0.5%, 1% or 2%) or placebo, with effect being measured based on improvement in the SALT score. At 24 weeks, 75.9% of patients treated with once-daily topical dosing of 1% STS-01 met the primary efficacy endpoint of a >30% improvement in SALT score, compared to 36.7% receiving placebo, the Company reports. In addition, 19% and 27% of patients on 1% and 2% STS-01, respectively, achieved total hair regrowth (SALT 0), compared to 3% receiving placebo with a clear dose response identified.
STS-01 was well tolerated with no major adverse events.
The Company states that STS-01 “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 maximize the efficacy of this mechanism and offer a cosmetically elegant topical cream.”
“These results are extremely encouraging,” says Arash Mostaghini, MD, MPH, Associate Professor of Dermatology at Brigham & Women’s Hospital in Boston, in a news release. “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 Pharma, adds, “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.”
Complete study results are expected to be presented at a future medical meeting.
