SiSaf’s bio-courier technology enables clinical trial success for topical treatment of mild to moderate Alopecia areata

SiSaf Ltd, a biopharmaceutical company that has developed a range of proprietary Bio-Courier® drug delivery technologies, today announced that a licensee of the ProSilic® variant of its technology has reported positive topline results from a randomised, placebo-controlled, multi-dose Phase II trial evaluating its topical treatment for mild to moderate (patchy) alopecia areata (AA), commonly known as spot baldness. This demonstrates the ability of SiSaf’s technology to deliver innovative new formulations that address stability, efficacy and side effect issues.

The API in the licensee’s drug product is a small molecule with a well-established safety profile in dermatology, which works through modulating the inflammatory response and the proliferation of T-cells by disruption of the signalling pathways. However, until now the instability of the molecule and its side effects have limited its efficacy and therapeutic application. Formulation with Bio-Courier technology has helped overcome these limitations and has transformed the molecule into a highly effective drug.

Dr Suzanne Saffie-Siebert, PhD, founder and Chief Executive Officer of SiSaf said:

“We formulated the molecule with ProSilic, one of the variants of our Bio-Courier delivery platform. This has stabilized the drug and has enabled controlled drug release, which reduces the molecule’s oxidative reactivity and boosts its anti-inflammatory potential. ProSilic also improves permeation into the skin epidermis and the hair follicle bulb target.”

“Among the range of Bio-Courier technologies, ProSilic is particularly well suited for dermal applications, such as seen here in treating spot baldness. By addressing the key drawbacks of the API, ProSilic creates a highly effective treatment option for Alopecia Areata – as indicated by the Phase II data.“

The Phase II study results announced by SiSaf’s licensee saw 158 participants with mild or moderate AA receive one of four doses - ranging from 0.25% to 2% — or placebo applied over 24 weeks. Around 76% of the 1% dose cohort met the study’s primary endpoint of a more than 30% improvement in severity of alopecia. 18% and 27% of the 1% and 2% dose cohorts, respectively, saw total hair regrowth, compared to just 3% of the placebo group. The Bio-Courier/ProSilic® formulated product was well tolerated with no major adverse events.

AA 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 AA patients suffer from the mild to moderate form of the disease, which is associated with a significant disease burden, including depression and anxiety.  The impact on quality of life for mild to moderate patients is equivalent to those with severe AA and yet no approved therapies exist for these patients.

Based on the Phase II data, the licensee is moving into late-stage clinical development and, if successful, it could become the first approved therapy and standard of care for mild to moderate AA, which represents over half of the estimated 800,000 AA patients in the US. Under the terms of its licensing agreement, the terms of which are undisclosed, SiSaf is entitled to milestone payments as well as royalties on product sales.

Dr Suzanne Saffie-Siebert, added, “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 demonstrated positive results in a Phase II clinical trial. These positive and highly encouraging data demonstrate the significant input of SiSaf’s delivery technology for dermal indications and open up wider partnering opportunities for Bio-Courier® formulated products for other topical applications, in both dermatology and ophthalmology. SiSaf has already generated promising data in relation to the treatment of psoriasis or hypertrophic and keloid scars.”

In addition to the SiSaf SIS-302-AA partnered program for Autoimmune Alopecia, SiSaf has two partnered programs in ophthalmology, SIS-201-CD and SIS-202-CDC for the treatment of corneal dystrophy. The company’s in house pipeline is focused on RNA treatments for musculoskeletal disorders and cancer.

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