Fact checked byKristen Dowd

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May 31, 2024
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Topical STS-01 demonstrates promising phase 2 results for alopecia areata treatment

Fact checked byKristen Dowd
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Key takeaways:

  • After 24 weeks of treatment, 75.9% of patients achieved 30% improvement in their alopecia.
  • 19% and 27% of those treated with 1% STS-01 and 2% STS-01, respectively, achieved total hair regrowth.

Soterios Pharma has announced positive topline results from its phase 2 trial evaluating STS-01 for the treatment of mild to moderate alopecia areata, according to a company press release.

After 24 weeks of once-daily topical treatment with 1% STS-01, 75.9% of patients met the study’s primary endpoint of achieving a greater than 30% improvement in Severity of Alopecia Tool score. In comparison, only 36.7% of patients receiving placebo achieved the same (P < .0096).

Alopecia 1
Soterios Pharma has announced positive topline results from its phase 2 trial evaluating STS-01 for the treatment of mild to moderate alopecia areata. Image: Adobe Stock.

Additionally, 19% of those treated with 1% STS-01 and 27% of those treated with 2% STS-01 achieved total hair regrowth vs. 3% of placebo-treated patients. No serious adverse events were reported.

“[These data give] us clarity and confidence in moving into late-stage clinical development for this product,” David Fleet, CEO of Soterios Pharma, said in the release. “We thank all the patients, investigators and health care staff who participated in this study.”

The company plans to release complete study results at a future medical meeting.