Business
Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Announces FDA Regulatory Pathway for EL-22, a Pioneering Obesity Therapy Targeting Fat Loss and Muscle Preservation
EL-22, a first-in-class myostatin asset, is being developed as a potential combination therapy with GLP-1 receptor agonists for obesity. It aims to address
About this update from Pmgc Holdings Inc.
[{"type":"text","content":"EL-22, a first-in-class myostatin asset, is being developed as a potential combination therapy with GLP-1 receptor agonists for obesity. It aims to address muscle loss, a common side effect of rapid weight loss from GLP-1-based treatments, by preserving muscle mass while reducing fat.The company plans to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) in 2025. NEWPORT BEACH, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Elevai Labs Inc. (Nasdaq: ELAB) (“Elevai” or the “Company”), a diversified holding company, subsidiary Elevai Biosciences Inc. (“Elevai Biosciences”), today announced the next steps in its regulatory strategy for EL-22, aimed at treating obesity and preserving muscle mass. In collaboration with KCRN Research, Inc., the Company is preparing for a pre-IND meeting with the FDA, anticipated in the first quarter of 2025. This meeting will establish the development pathway for EL-22, clarifying any additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission. EL-22 is an engineered probiotic designed to express myostatin on its surface, leveraging the myostatin pathway to support muscle health. Preclinical studies, including a 2022 study 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. “Regulatory precedent for myostatin-based therapies in combination with GLP-1 receptor agonists are promising,” said Deniel Mero, Co-founder of Elevai Biosciences. “Leveraging existing data from our Korean licensing partner, including human safety studies, provides a strong foundation to accelerate the IND process and subsequent U.S. clinical trials. We are excited about EL-22’s potential to redefine obesity care by combining effective weight loss with muscle preservation.” Elevai aims to file the IND in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment. About Elevai Labs, Inc.Elevai Labs Inc. specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to o...