SiSaf's Bio-Courier Tech Enables Clinical Trial Success for Mild to Moderate Alopecia Areata Treatment

SiSaf Ltd, a biopharmaceutical company based in Guildford, UK, has announced promising results from a Phase II clinical trial conducted by one of its licensees. The trial tested a novel treatment for mild to moderate alopecia areata (AA), a condition also known as spot baldness. The treatment uses SiSaf’s Bio-Courier® technology, particularly the ProSilic® variant, to deliver the active pharmaceutical ingredient (API) effectively.

The trial involved 158 participants with mild to moderate AA, who were given one of four doses (ranging from 0.25% to 2%) or a placebo over a 24-week period. The results were encouraging: approximately 76% of the participants receiving the 1% dose saw a more than 30% improvement in their condition. Furthermore, 18% and 27% of the participants receiving the 1% and 2% doses, respectively, experienced total hair regrowth, compared to just 3% in the placebo group. The treatment was well tolerated, with no significant adverse events reported.

Alopecia areata is an autoimmune disease where the body's immune system attacks hair follicles, leading to patchy hair loss. This condition affects an estimated 800,000 people in the US alone, with over half experiencing mild to moderate symptoms. Currently, there are no approved therapies specifically for this subset of patients, making these trial results particularly significant.

The API used in the licensee's product has a well-documented safety profile and works by modulating the inflammatory response and T-cell proliferation. However, its instability and side effects have previously limited its effectiveness. SiSaf’s Bio-Courier technology has addressed these issues by stabilizing the molecule, enabling controlled drug release, and reducing oxidative reactivity. This has enhanced the drug’s anti-inflammatory properties and its ability to penetrate the skin and target hair follicle bulbs.

Dr. Suzanne Saffie-Siebert, founder and CEO of SiSaf, highlighted the significance of the ProSilic variant in dermal applications, noting its effectiveness in treating alopecia areata. The success of this Phase II trial paves the way for late-stage clinical development. If the subsequent trials are successful, this treatment could become the first approved therapy and standard of care for mild to moderate AA.

Beyond alopecia areata, the positive trial results also underscore the broader potential of SiSaf's Bio-Courier technology. The company has generated promising data for other dermatological applications, including psoriasis and hypertrophic and keloid scars. Additionally, SiSaf is involved in partnered programs for ophthalmological conditions such as corneal dystrophy and is expanding its pipeline to include RNA treatments for musculoskeletal disorders and cancer.

SiSaf's Bio-Courier platform is unique in its combination of organic materials with inorganic silicon, enhancing the stability, solubility, safety, and targeting capabilities of various molecules, including nucleic acids. This innovative approach has positioned SiSaf as a leader in RNA therapeutics, with a growing patent portfolio and robust research infrastructure.

The company's founder, Dr. Saffie-Siebert, is a renowned biomaterials specialist, and under her leadership, SiSaf continues to push the boundaries of drug delivery technology. The recent Phase II trial results are a testament to the potential of SiSaf’s technology to revolutionize treatment options for dermatological conditions and beyond.

SiSaf remains committed to advancing its research and expanding its partnerships to maximize the impact of its Bio-Courier technology across multiple therapeutic areas.