Northstrive Biosciences Announces Positive FDA Response Supporting A Submission of IND for a Phase 2 Clinical Trial for EL-22 in Combination with GLP-1 Receptor Agonist for Obesity Treatment
- 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.
The FDA's responses indicated, amongst other things, that it agreed that (i) Northstrive's pharmacology studies support EL-22 activity; (ii) Northstrive's nonclinical studies appear adequate to support the safety and activity of EL-22 in overweight and obese human populations, and (iii) data from Northstrive's Phase 1 study and completed nonclinical studies appear adequate to allow the initiation of the proposed Phase 2 clinical trial. Northstrive believes the FDA's preliminary responses regarding the pre-IND meeting were sufficient and will forego the pre-IND meeting. Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate a Phase 2 clinical trial to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment. Northstrive is in ongoing discussions with Current Good Manufacturing Practices (cGMP) manufacturing partners to prepare the production of EL-22.
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 nonclinical data package of EL-22, as well as the Phase 1 study conducted in South Korea, appear adequate to support the safety and activity in an obese patient population," stated Deniel Mero, Co-founder of Northstrive Biosciences. "This positive reinforcement from the FDA is a critical milestone in the development of EL-22 to address one of obesity's biggest unmet needs; the preservation of muscle for patients on GLP-1 therapies."
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, leverages an engineered probiotic approach to address obesity's pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com.
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com.
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1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
