Scinai Immunotherapeutics Reports Promising In-Vivo Results for Psoriatic Skin Model

JERUSALEM, July 15, 2024 -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biotechnology firm dedicated to developing biological products for inflammation and immunology, and offering Contract Development and Manufacturing Organization (CDMO) services through its Scinai Bioservices unit, has announced significant findings from a preclinical study on its innovative NanoAb, an anti IL-17A/F VHH antibody fragment. This new treatment, designed as a local intralesional biological therapy, aims to address the needs of patients with mild to moderate plaque psoriasis.

There are approximately 13 million individuals diagnosed with plaque psoriasis in the major markets including the US, EU5, and Japan. About half of these patients have mild psoriasis, while around 28% suffer from moderate forms of the disease. These patients often endure visible and uncomfortable lesions that can negatively affect their social and mental well-being, particularly when the lesions appear on sensitive areas such as the face, genitals, scalp, palms, and soles.

Current treatments for mild to moderate plaque psoriasis mainly involve topical corticosteroids and phototherapy. These require frequent application, pose risks of local adverse effects, and often result in low patient adherence. Moderate to severe cases are usually treated with biologics and JAK inhibitors, which, though effective, are expensive, require chronic use, and carry significant health risks over time. Thus, there is a considerable need for better treatment options for mild to moderate cases.

Scinai's product candidate aims to overcome the limitations of existing treatments. It is a biologic designed for local, intradermal delivery into psoriatic lesions with a short, nearly painless needle. This approach aims to provide patients with a less frequent treatment option that combines the specificity and potency of biologics, while minimizing the risk of local and systemic side effects.

The study, led by Prof. Amos Gilhar of the Technion Israel Institute of Technology, sought to prove that Scinai's NanoAb, targeting the IL-17A and IL-17F cytokines implicated in plaque psoriasis, could achieve anti-inflammatory effects comparable to corticosteroids and systemic biologics. In this study, human skin was grafted onto mice and psoriasis was induced using activated human peripheral blood mononuclear cells from psoriasis patients. The mice were then divided into groups and treated over two weeks. The effects were monitored for an additional three weeks post-treatment.

The study compared Scinai's NanoAb to two other approved drugs: Betamethasone, a topical corticosteroid, and Secukinumab, a systemic monoclonal antibody targeting IL-17A. An irrelevant NanoAb served as a control. The results were measured through cytokine levels in the skin tissues and histopathological analysis to assess skin structure and integrity.

The findings confirmed the ability of Scinai's NanoAb to neutralize both IL-17A and IL-17F isoforms, significantly reducing their levels in psoriatic skin tissue. Statistical analysis showed that the NanoAb's effect on inflammatory markers was comparable to that of Betamethasone and Secukinumab, supporting the hypothesis that intralesional injections targeting IL-17 can reduce psoriatic lesion severity and improve skin integrity.

Dr. Tamar Ben-Yedidia, Chief Scientist at Scinai, expressed optimism about these results, noting the potential for a novel treatment that meets the needs of mild to moderate plaque psoriasis patients. Traditionally, innovations in autoimmune disease treatments have focused on severe cases, leaving mild cases with less effective treatments. Scinai's aim is to provide a highly effective, specific, convenient, and safe local biological treatment for plaque psoriasis lesions.

Looking ahead, Scinai plans to refine dosing and drug half-life and conduct a longer duration in-vivo animal study later in 2024, followed by pre-clinical toxicology studies before initiating a first-in-human clinical trial in late 2025.

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