PMGC submits pre-IND meeting request to FDA for EL-22 in obesity

Northstrive Biosciences has submitted a pre-Investigational New Drug, or pre-IND, meeting request to the FDA for EL-22, a novel myostatin asset aimed at preserving muscle while on weight loss treatments. A pre-IND meeting with the FDA is expected in Q2 to discuss nonclinical studies and Northstrive Biosciences’ clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists being used in obese patients. Northstrive Biosciences seeks guidance from the FDA on the acceptability of the nonclinical studies conducted to date and the clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists being used to treat subjects that are overweight or obese. The FDA is expected to respond to the pre-IND meeting request within Q1. If this request is granted, the FDA’s response letter will permit a meeting scheduled for Q2. 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. Upon regulatory confirmation, Northstrive Biosciences 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.