Scinai Immunotherapeutics Announces Positive Regulatory Feedback from the Paul Erlich Institute (the PEI) for its drug development program towards Phase 1/2a clinical trial of its anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis Clarified preclinical toxicology and clinical program for Plaque Psoriasis First-in-human with intralesional injections for the treatment of patients with mild to moderate Plaque Psoriasis The PEI had requested to see data of efficacy in blocking IL-17F; this data became available as per the Company's announcement last week describing the positive in vivo proof of concept results. The PEI accepted the Company's position that toxicology studies can be conducted in pigs rather than in Non-Human Primates. The PEI accepted the Company's position to compare the SCN-1 to placebo directly in patients with mild to moderate plaque psoriasis while skipping the need for testing in healthy volunteers, resulting in a phase 1/2a clinical trial, which will assess both safety and efficacy in the same trial.
The PEI agreed to compare SCN-1 to placebo on the same human subject, a strategy that could significantly reduce the number of patients required for the clinical trial The PEI commented that the manufacturing process looks well developed and that controls and specifications presented are acceptable The Phase 1/2a study is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2025 with readout in 2026. JERU.