Scinai Immunotherapeutics (NASDAQ: SCNI), a biotechnology company focused on developing inflammation and immunology (“I&I”) biological products and on providing contract development and manufacturing organization (“CDMO”) services through its Scinai Bioservices business unit, has received the minutes of meeting from a recent Scientific Advice (“SA”) with the Paul Erlich Institute, Federal Institute for Vaccines and Biomedicines (“PEI”). According to the announcement, this is the European equivalent to a pre-IND meeting with the U.S. Food and Drug Administration in the United States as well as acceptable guidance for Investigational Medicinal Product Dossier (“IMPD”) filing with the European Medicines Agency (“EMA”). The company noted that the minutes of meeting reflect positive regulatory feedback that can be referenced as drug-development plans move forward for its anti-IL-17A/F nanoAb (SCN-1) in plaque psoriasis phase 1/2a clinical trial. Specifically, the minutes provided clarification for the 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 also requested to see data of efficacy in blocking IL-17F; accepted the company’s position that toxicology studies can be conducted in pigs rather than in nonhuman primates; 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; agreed to compare SCN-1 to placebo on the same human subject; and noted that the manufacturing process looks well developed with acceptable controls and specifications.Scinai Immunotherapeutics anticipates the preclinical trial will start in the second half of 2025. “It is encouraging to receive such a supportive regulatory summary for our plans,” said Scinai Immunotherapeutics chief scientist Dr. Tamar Ben-Yedidia in the press release. “The PEI agreed with the unmet need of the patients with mild-to-moderate psoriasis for a better therapy and accepted our pre-clinical and clinical plans that will allow faster development of this product.”
To view the full press release, visit https://ibn.fm/KInAu
About Scinai Immunotherapeutics Ltd.
Scinai Immunotherapeutics is a biopharmaceutical company with two complementary business units: one focused on in-house development of inflammation and immunology (“I&I”) biological therapeutic products beginning with an innovative, derisked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique contract development and manufacturing organization (“CDMO”) providing biological drug development, analytical methods development, clinical cGMP manufacturing, and preclinical and clinical trial design and execution services to early-stage biotech drug-developmet companies. For more information, visit the company’s website at www.Scinai.com.
NOTE TO INVESTORS: The latest news and updates relating to SCNI are available in the company’s newsroom at https://ibn.fm/SCNI
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