- Northstrive Biosciences receives positive FDA feedback for a Phase 2 trial of EL-22 with GLP-1 receptor agonists.
- EL-22 aims to address obesity by preserving muscle mass during weight loss treatments.
- Phase 2 clinical trials are expected to be initiated post-2025 IND application submission.
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), has announced a significant milestone in its clinical development endeavors as it received positive preliminary feedback from the U.S. Food and Drug Administration (FDA). This feedback pertains to their pre-IND meeting for EL-22, an engineered probiotic intended for use in combination with GLP-1 receptor agonists for obesity treatment.
The FDA's response confirms that Northstrive's pharmacology and nonclinical studies satisfactorily demonstrate the activity and safety of EL-22 in overweight and obese populations. This validation from the FDA removes a major development hurdle, allowing Northstrive to proceed with its plan to file an Investigational New Drug (IND) application by 2025, which would facilitate the initiation of Phase 2 clinical trials.
EL-22 targets the myostatin pathway, aiming to enhance muscle health during weight loss treatments. This approach addresses a prevalent concern in obesity management, where GLP-1 receptor agonists can result in loss of muscle mass. Northstrive's previous Phase 1 clinical trials in South Korea indicated that the treatment was generally well-tolerated and safe among healthy volunteers.
While the FDA's positive response propels Northstrive forward, the company is concurrently engaging with manufacturing partners to prepare for the production phase of EL-22 under Current Good Manufacturing Practices (cGMP). The upcoming Phase 2 trials will critically assess the efficacy of EL-22 in preserving muscle mass during weight loss therapy, a feature that could distinguish it in the competitive obesity treatment market.
Northstrive's initiative exemplifies a novel approach in addressing obesity's core challenges, reinforcing the company's commitment to advancing innovative biopharmaceutical solutions that align with current clinical needs.
