regulatory
confidence high
sentiment positive
materiality 0.70
PMGC subsidiary Northstrive gets FDA support for IND submission of EL-22 with GLP-1 for obesity
PMGC Holdings Inc.
- FDA agreed pharmacology studies support EL-22 activity and nonclinical studies appear adequate for safety/activity in overweight/obese humans.
- Phase 1 and completed nonclinical data deemed adequate to allow initiation of a proposed Phase 2 clinical trial.
- Northstrive aims to file IND in 2025 and start Phase 2 trial evaluating EL-22 combined with GLP-1 receptor agonists.
- EL-22 is a patent-pending engineered probiotic designed to express myostatin, targeting muscle preservation during weight loss.
- Preclinical data in mdx mice showed significant physiological and functional improvements; Phase 1 in South Korea showed good tolerability.