- Lead asset EL-22 is leveraging a myostatin-engineered probiotic approach to address obesity's pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
- Northstrive Biosciences Inc. is preparing the necessary steps to leverage existing EL-22 animal data and human safety studies from Korean licensing partner to arrange an Investigational New Drug filing with the U.S. Food and Drug Administration.
- EL-32 is a pre-clinical, engineered probiotic expressing dual myostatin & activin-A, focusing on two clinically validated targets that play an important role in regulating muscle.
EL-22: Preparing for FDA Pre-IND Meeting Request
Northstrive is finalizing preparations for a pre-Investigational New Drug ("pre-IND") meeting request with the U.S. Food and Drug Administration ("FDA"). Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second quarter of 2025. Northstrive has completed necessary translations and compiled preclinical and clinical inquiries from existing data from its South Korean licensing partner to support the meeting request. Concurrently, Northstrive is seeking a U.S.-based Current Good Manufacturing Practices (cGMP) manufacturing partner for EL-22.
EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements. 1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers.
Upon regulatory confirmation, Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment.
EL-32: Engaged CRO for Preclinical Study
Northstrive has entered into a research agreement with a leading preclinical contract research organization (CRO) specializing in metabolic disorders. The research agreement will support a planned study to evaluate EL-32, an engineered probiotic expressing dual myostatin and activin-A inhibitors, both as a monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The focus of the study will be on glycemic control and body composition in diet-induced obese (DIO) mice.
"We are laying the groundwork to move both programs forward as potential treatments for obesity," said Deniel Mero, Co-founder of Northstrive Biosciences. "The FDA has cleared other myostatin-based therapies to start clinical trials in combination with GLP-1 receptor agonists, which gives us confidence and a precedent to follow a similar path by leveraging existing data from our Korean licensing partner to accelerate our pre-IND process."
Upcoming Presentation
Northstrive will present its novel obesity drug candidates at the exclusive UCLA Obesity Symposium, "Anti-Obesity Treatments: Challenges and Emerging Solutions," organized by the UCLA Metabolism Theme, an initiative of the UCLA David Geffen School of Medicine. The presentation, titled "Myostatin-Engineered L. Casei Bacteria As A Muscle Preserving Therapeutic," is scheduled for Friday, February 7, 2025.
About Northstrive Biosciences
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive's lead asset, EL-22, is leveraging an engineered probiotic approach to address obesity's pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com.
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1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
