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Northstrive Biosciences Receives Preliminary Responses And Commentary From FDA Regarding Scheduled Type B Pre-IND Meeting

Benzinga·04/24/2025 12:05:03
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  • Northstrive Biosciences received preliminary meeting responses from the FDA regarding Northstrive's nonclinical studies and clinical development plans for EL-22, administered in combination with GLP-1 receptor agonists.
  • Northstrive believes the FDA responses encourage a path forward for filing an IND application to conduct a Phase 2 clinical trial in overweight or obese patients.
  • EL-22 is leveraging a myostatin-engineered probiotic approach to address obesity's pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.

     

NEWPORT BEACH, Calif., April 24, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. ("Northstrive"), a subsidiary of PMGC Holdings Inc. (NASDAQ:ELAB) (the "Company," "PMGC," "we," or "our"), announced that it has received preliminary responses and commentary from the U.S. Food and Drug Administration ("FDA") regarding its scheduled Type B pre-Investigational New Drug ("pre-IND") meeting. Northstrive initially requested this meeting with the FDA to discuss nonclinical studies and Northstrive Biosciences' clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists. Northstrive believes the FDA's responses support an IND submission for the initiation of a proposed Phase 2 clinical study.