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SIS-302-AA is an investigational topical drug under development for the treatment of autoimmune alopecia areata. It utilizes SiSaf’s proprietary Bio-Courier technology, specifically the ProSilic delivery platform, which is designed to enhance dermal application and efficacy of active pharmaceutical ingredients (APIs). In a Phase II clinical trial involving 158 participants with mild or moderate alopecia areata, various doses (0.25% to 2%) were tested over 24 weeks. The results showed that approximately 76% of patients in the 1% dose cohort achieved at least a 30% improvement in alopecia severity, and up to 27% experienced total hair regrowth at higher doses—significantly outperforming placebo. The formulation was well tolerated with no major adverse events reported. SiSaf is advancing this candidate toward late-stage clinical development as a potential first approved therapy for mild to moderate alopecia areata[6][9].
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