STS-01 / Soterios - LARVOL DELTA

Investigating the immunomodulatory mechanism of dithranol in alopecia areata through blood-based in vitro studies (ESDR 2025) - "A novel controlled-release nanoparticle formulation of topical STS01 (dithranol/ProSilic cream) recently demonstrated clinical efficacy in a phase 2 trial, but the immunological mechanisms underlying its therapeutic effect remain unclear...These results suggest that dithranol attenuates both monocyte- and T cell-associated pro-inflammatory cytokine activity, providing mechanistic insight into its clinical benefit. Ongoing efforts aim to validate these findings in ex vivo skin models using biopsies from alopecia patients to further evaluate the compound's topical immunomodulatory effects."

Immunomodulating • Preclinical • Alopecia • Immunology • CD4 • IFNG • IL17A • IL6 • TNFA

Soterios Pharma Announces Positive Topline Results from Phase II Study of STS-01 in the Treatment of Mild / Moderate Alopecia Areata (PRNewswire) - P2 | N=158 | NCT06402630 | Sponsor: Soterios Ltd | "Soterios Pharma...announced positive topline results from its randomised, placebo-controlled, multi-dose Phase II trial evaluating STS-01 as a treatment for mild / moderate 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. STS-01 was well tolerated with no major adverse events. Complete study results are expected to be presented at a future medical meeting."

P2 data • Alopecia • Dermatology • Immunology

SOT01: A Phase 2 Placebo Controlled, Clinical Trial Designed to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA) (clinicaltrials.gov) - P2 | N=158 | Completed | Sponsor: Soterios Ltd

New P2 trial • Alopecia • Dermatology • Immunology