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Northstrive Biosciences Inc. Schedules Pre-IND Meeting with FDA for EL-22, an Obesity Therapy Targeting Fat Loss and Muscle Preservation in Combination with GLP-1
Northstrive Biosciences Inc. has scheduled a pre-IND meeting with the U.S. Food and Drug Administration for April 23, 2025.EL-22 is leveraging a
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[{"type":"text","content":"Northstrive Biosciences Inc. has scheduled a pre-IND meeting with the U.S. Food and Drug Administration for April 23, 2025.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., March 10, 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 scheduled a pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) for Wednesday, April 23, 2025. Northstrive will have a Type B pre-IND meeting with the FDA to discuss the path forward for filing an IND for EL-22 as a combination treatment with GLP-1 for muscle preservation. EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements.1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers. “The scheduled pre-IND meeting is a crucial step in our development of EL-22 and underscores our commitment to advancing this potential breakthrough therapy,” said Deniel Mero, Co-founder of Northstrive Biosciences. “We expect to walk away from the meeting with a clear path for moving into human trials, targeting one of obesity’s biggest unmet needs; the preservation of muscle for patients on GLP-1 therapies.” Upon FDA feedback and guidance, Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment. About Northstrive Biosciences Inc. Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive’s lead asset, EL-22, is leveraging an engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, includ...