Elevai Biosciences Inc., a subsidiary of Elevai Labs Inc., announced on October 22, 2024, that it has engaged KCRN Research, Inc., a global contract research organization (CRO). KCRN will support the company's initial efforts to prepare for an Investigational New Drug (IND) application to the FDA for EL-22.
EL-22 is being developed for the treatment of obesity and muscle loss preservation, leveraging an engineered probiotic approach that targets the clinically validated myostatin pathway. KCRN specializes in bridging the regulatory gap for Korean-originated assets and preparing early-phase drug development projects for the FDA.
The company and KCRN are gathering the necessary development work for the IND submission, including preparing and scheduling a pre-IND meeting with the FDA. Elevai intends to complete an IND submission in 2025 and initiate clinical trials in the U.S. to evaluate EL-22 in combination with GLP-1 receptor agonists.
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