SiSaf Advances in Alopecia Treatment with Phase II Trial of Bio-Courier® Technology

by Halyna Buvailo, PhD          News

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In a new development in the field of dermatological therapeutics, SiSaf Ltd, a biopharmaceutical company based in Guildford, UK, has reached a pivotal stage for its novel treatment for alopecia areata. The company, renowned for its work in RNA therapeutics for rare diseases, announced the completion of patient enrollment for a Phase II clinical trial. This trial is notable for its focus on a treatment for mild-to-moderate alopecia areata using SiSaf’s proprietary Bio-Courier delivery technology.

Innovative Approach to Treating Hair Loss

Alopecia areata, an autoimmune condition that leads to patchy hair loss, affects a significant portion of the population, with more than half experiencing it in a mild to moderate form. 

SiSaf's Bio-Courier technology, leveraging hybrid silicon lipid nanoparticles, is at the core of the trial's drug product. This advanced delivery system is designed to optimize the control of drug release, reducing oxidative reactivity and boosting anti-inflammatory properties. Crucially, it also enables effective permeation into the target areas - the skin epidermis and the hair follicle bulb.

The Phase II trial is a randomized, placebo-controlled study involving 158 patients. It aims to evaluate the safety and efficacy of the topical treatment compared to a placebo, focusing specifically on adults with mild to moderate alopecia areata, as indicated by a SALT score of less than 50.

Dr. Suzanne Saffie-Siebert, the founder and CEO of SiSaf, expressed confidence in the potential of their Bio-Courier delivery platform. This confidence is bolstered by a wealth of preclinical data that demonstrated the safety and effectiveness of the platform for various active pharmaceutical ingredients (APIs) and targets. The move into human Phase II trials marks a significant step forward for the company, with results eagerly anticipated in the next year.

This clinical trial is not only a testament to SiSaf's innovative approach in drug delivery but also underscores the broader potential of their Bio-Courier technology in dermatological indications. The treatment modulates the inflammatory response and T-cell proliferation by disrupting signaling pathways, offering a new avenue in the management of alopecia areata.

Beyond alopecia, the company’s leading programs include siRNA treatments for Osteopetrosis ADO2 and Corneal Dystrophy, with ongoing efforts to extend its pipeline to oncology and other fields. The company's unique approach to RNA delivery, characterized by improved stability, safety, and transfection efficiency, positions it as a promising player in the field.

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