Northstrive Biosciences, a subsidiary of PMGC Holdings Inc. (ELAB), Thursday announced that it has received encouraging preliminary feedback from the U.S. Food and Drug Administration following its Type B pre-IND meeting request.
The FDA indicated that Northstrive's pharmacology and nonclinical studies support the safety and activity of its engineered probiotic candidate, EL-22, particularly in overweight and obese populations.
Given the FDA's supportive responses, Northstrive will forgo the pre-IND meeting and plans to submit an Investigational New Drug application in 2025 to begin a Phase 2 clinical trial evaluating EL-22 in combination with GLP-1 receptor agonists for obesity treatment. EL-22, designed to express myostatin on its surface, aims to preserve muscle mass a key challenge for patients on GLP-1 therapies.
The candidate has shown promising results in preclinical studies and was well-tolerated in a Phase 1 trial in South Korea. Production planning is underway with cGMP partners.
ELAB is currently trading at $2.54 down $0.37 or 12.68 percent on the Nasdaq.
For comments and feedback: editorial@rttnews.com