Scinai Immunotherapeutics Receives Positive Regulatory Feedback for Phase 1/2a in Plaque Psoriasis with Anti-IL-17 nanoAb

Scinai Immunotherapeutics has announced promising feedback from the Paul Ehrlich Institute (PEI) regarding its development program for an anti-IL-17A/F nano antibody (SCN-1) aimed at treating plaque psoriasis. The German regulatory body has provided guidance that will enable Scinai to proceed efficiently toward a Phase 1/2a clinical trial.

The PEI has requested data on the efficacy of SCN-1 in blocking IL-17F, which was recently made available, demonstrating positive in vivo proof-of-concept results. Additionally, the PEI has agreed with Scinai's approach to conduct toxicology studies in pigs instead of non-human primates, and to directly compare SCN-1 to a placebo in patients with mild to moderate plaque psoriasis, bypassing the need for testing in healthy volunteers. This strategy is expected to expedite the clinical trial process, enabling the assessment of both safety and efficacy in a single trial.

The proposed Phase 1/2a study anticipates involving approximately 24 patients and is expected to begin in the latter half of 2025, with results available in 2026.

During a scientific advisory meeting held via video conference on June 4, 2024, Scinai presented its development plans, including data from non-clinical studies and its strategies for toxicology and clinical trials. Scinai highlighted the advantages of using an anti-IL-17 nano antibody for localized treatment of psoriatic lesions, which could address an unmet medical need for patients with mild to moderate psoriasis. Such patients often do not respond well to current treatments, which include corticosteroid creams and phototherapy.

The PEI recognized the potential benefits of SCN-1, noting that the manufacturing process and controls are well developed. The regulatory body also accepted the company's approach to conducting toxicology studies in pigs, which translates to significant time and cost savings. Furthermore, the PEI supported the proposed clinical trial design, including the recruitment of patients with mild to moderate plaque psoriasis and the direct comparison of SCN-1 to a placebo, which should speed up recruitment and reduce costs.

Scinai expects to prepare for a pre-clinical toxicology study before commencing its Phase 1/2a clinical trial in 2025. The company aims to address the considerable unmet market need for improved treatments for plaque psoriasis, a condition affecting about 13 million people in major global markets. Current treatments for mild to moderate psoriasis, such as corticosteroids and phototherapy, require frequent use and have associated risks, including skin atrophy and the development of tolerance. Treatments for more severe forms of the disease, like biologics and JAK inhibitors, are expensive, require chronic use, and come with long-term health risks.

Scinai's candidate, designed for local intradermal delivery into psoriatic lesions, promises to offer the high specificity and potency of biologics with fewer local side effects than corticosteroids and fewer systemic side effects than systemically administered biologics. This approach could provide a less demanding treatment regimen for patients.

Dr. Tamar Ben-Yedidia, Scinai's Chief Scientist, expressed optimism about the supportive regulatory feedback, noting that the PEI acknowledged the unmet need for better therapies for mild to moderate psoriasis and accepted the company's pre-clinical and clinical plans. The company plans to fine-tune dosing and drug half-life and conduct a longer-duration in vivo animal study in late 2024, followed by a pre-clinical toxicology study before starting the clinical trial in late 2025.

Scinai Immunotherapeutics Ltd. is a biopharmaceutical company dedicated to developing biological therapeutic products for inflammation and immunology through a novel pipeline of nanosized VHH antibodies, as well as offering contract development and manufacturing services.