Positive top-line Phase II results for Soterios’ STS-01 in alopecia

Privately-held UK clinical-stage firm Soterios Pharma has announced positive multi-dose Phase II trial evaluating STS-01 as a treatment for mild/moderate alopecia areata (AA).

At 24 weeks, 75.9% of patients treated with once-daily topical dosing of 1% STS-01 met the primary efficacy endpoint (achieving >30% improvement in SALT score) compared to 36.7% receiving placebo (p<0.0096).  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.

Noting that STS-01 was well tolerated with no major adverse events, chief executive David Fleet said: "This data gives us clarity and confidence in moving into late-stage clinical development for this product.”