SiSaf Announces Completion of Patient Enrolment in Phase II Trial of Bio-Courier® Drug Formulation for the Treatment of Mild/Moderate Alopecia Areata
13 December 2023
The Phase II clinical trial is testing the safety and efficacy for the treatment of mild-to-moderate alopecia areata, an autoimmune condition leading to patchy hair loss
SiSaf Ltd, a biopharmaceutical company developing RNA therapeutics for rare diseases, today announced that an undisclosed licensee of its Bio-Courier delivery technology has completed target patient enrolment for the Phase II clinical trial of a treatment for mild-to-moderate (patchy) alopecia areata.
The trial’s drug product uses one of the variants of SiSaf’s Bio-Courier delivery platform to enable control of drug release, in order to reduce the drug’s oxidative reactivity and improve its anti-inflammatory potential whilst allowing permeation into the skin epidermis and the hair follicle bulb target. The topical formulation works through modulating the inflammatory response and the proliferation of T-cells by disruption of the signalling pathways.
Alopecia areata is understood to be an autoimmune disease under which cells in the immune system surround and attack hair follicles leading to patchy hair loss. Over half of Alopecia areata patients suffer from the mild to moderate form of the disease.
The study is a randomized, placebo-controlled trial in 158 patients and will evaluate the safety and efficacy of the drug formulation as a topical treatment compared to placebo in adult subjects with mild to moderate alopecia areata (SALT score <50).
Dr Suzanne Saffie-Siebert, PhD, founder and Chief Executive Officer of SiSaf said, “We have a wealth of preclinical data demonstrating the safety and efficacy of our Bio-Courier delivery platform for a wide range of APIs and targets. We are pleased that one of our formulations has now entered human Phase II trials and we look forward to the results in Q2 next year. This treatment demonstrates the potential of SiSaf’s delivery technology for dermal indications.”
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About SiSaf
SiSaf is an RNA therapeutics company with a proprietary delivery platform. Its lead programs are a siRNA treatment for Osteopetrosis ADO2 and a partnered siRNA treatment for Corneal Dystrophy. The company is in the process of expanding its pipeline to other fields, including oncology.
SiSaf’s proprietary Bio-Courier delivery platform uses silicon stabilized hybrid lipid nanoparticles (sshLNP) to improve the stability, safety, and transfection efficiency of RNA. sshLNP remove the need for an ultra-cold chain and unlike conventional lipid nanoparticles, they can be manufactured empty and the RNA can be introduced in a separate step.
Led by founder and leading biomaterials specialist Dr. Suzanne Saffie-Siebert, SiSaf is a venture capital-backed private company. Headquartered in Guildford, UK, it has fully integrated research labs and bio-analytical facilities, a scalable technology to fast-track development, and a growing patent estate with extensive freedom to operate.
To learn more, please visit www.sisaf.com
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