Northstrive Biosciences, a subsidiary of PMGC Holdings, received positive feedback from the FDA regarding its pre-IND meeting request for EL-22, a probiotic designed to be used in conjunction with GLP-1 receptor agonists for weight loss. The FDA indicated Northstrive’s existing pharmacology and nonclinical studies sufficiently support EL-22’s safety and activity in overweight and obese populations, paving the way for a Phase 2 clinical trial. This development allows Northstrive to bypass the pre-IND meeting and proceed directly to an IND application in 2025.
This news is particularly noteworthy due to the growing prominence of GLP-1 receptor agonists in obesity treatment. A key challenge with these therapies is muscle loss, which EL-22 aims to mitigate. Positive FDA feedback validates Northstrive’s approach and suggests a potential solution for improving patient outcomes with existing weight-loss treatments. This could position EL-22 as a valuable companion therapy, enhancing the overall efficacy and benefits of GLP-1 receptor agonists.
EL-22 is an engineered probiotic that expresses myostatin on its surface, targeting the myostatin pathway to support muscle health. Preclinical studies have shown promising results in improving muscle function. A Phase 1 trial in South Korea also confirmed the safety and tolerability of EL-22 in healthy volunteers. Northstrive is currently working with cGMP manufacturing partners to prepare for EL-22 production for the upcoming Phase 2 trial.
This positive interaction with the FDA represents a significant step forward for Northstrive and the development of EL-22. It establishes a clear regulatory path and sets the stage for a Phase 2 clinical trial that will evaluate the combination of EL-22 and GLP-1 receptor agonists in obese patients. Positive results from this trial could lead to a novel approach to obesity management, addressing the critical need for muscle preservation during weight loss. This could have a significant impact on the obesity treatment landscape, offering patients a more comprehensive and beneficial weight loss strategy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
