SiSaf’s Bio-Courier Technology Achieves Clinical Success for Topical Alopecia Areata Treatment

SiSaf Ltd, a biopharmaceutical company specializing in drug delivery technologies, announced positive topline results from a phase II clinical trial of a licensee's topical treatment for mild to moderate alopecia areata (AA). The treatment uses SiSaf’s ProSilic variant of the Bio-Courier delivery technology, demonstrating the technology's ability to address stability, efficacy, and side effect issues.

The randomized, placebo-controlled trial involved 158 participants with mild to moderate AA, a condition characterized by patchy hair loss due to an autoimmune response. The study evaluated 4 doses of the treatment over 24 weeks. The results were promising: 76% of the 1% dose cohort achieved a more than 30% improvement in AA severity, and 18% and 27% of the 1% and 2% dose cohorts, respectively, experienced total hair regrowth, compared to just 3% in the placebo group. The treatment was well tolerated with no major adverse events.

Dr Suzanne Saffie-Siebert, CEO of SiSaf, commented, “Formulating the molecule with ProSilic has stabilized the drug and enabled controlled release, reducing oxidative reactivity and enhancing its anti-inflammatory potential. This has transformed the molecule into a highly effective treatment for alopecia areata.”

The licensee's product, formulated with ProSilic, could become the first approved therapy for mild to moderate AA, which affects over half of the estimated 800,000 patients with AA in the United States. This development represents a significant advancement, offering a potential standard of care for a condition with substantial impact on quality of life. With these positive phase II results, the licensee plans to move into late-stage clinical development.

Dr Saffie-Siebert added, “These encouraging data demonstrate the significant potential of SiSaf’s Bio-Courier technology for dermal indications and open up wider partnering opportunities for other topical applications in dermatology and ophthalmology.”

Reference

Soterios Pharma announces positive topline results from phase II study of STS-01 in the treatment of mild/moderate alopecia areata. News release. PR Newswire. May 30, 2024. Accessed June 12, 2024.
https://en.prnasia.com/releases/apac/soterios-pharma-announces-positive-topline-results-from-phase-ii-study-of-sts-01-in-the-treatment-of-mild-moderate-alopecia-areata-448823