PMGC announces preliminary responses from U.S. FDA on EL-22

Northstrive Biosciences 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 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 Northstrive’s pharmacology studies support EL-22 activity; Northstrive’s nonclinical studies appear adequate to support the safety and activity of EL-22 in overweight and obese human populations, and 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 manufacturing partners to prepare the production of EL-22.