SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) is advancing its lead drug candidate GEP-44 into a key preclinical phase, initiating a Good Laboratory Practice (GLP) toxicology and pharmacology program aligned with U.S. Food and Drug Administration (FDA) requirements. This program is intended to support an Investigational New Drug (IND) application and represents a necessary step before first-in-human clinical trials. The company is positioning itself as an agile entrant in the rapidly expanding GLP-1 market, having developed a patented second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound from Syracuse University.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, emphasized the significance of this milestone. "Initiating these U.S. Food and Drug Administration IND-enabling studies is a major milestone for SureNano Science and GlucaPharm, moving us firmly towards the final, rigorous evaluation in various clinical phases before entering the clinic," said Dr. Pandey. "Partnering with a globally renowned CRO like LabCorp will ensure our studies meet the highest regulatory standards. This package is vital to de-risk our lead candidate and is designed to support our strategy of launching a Phase I clinical trial in Australia."
The full article detailing this development is available at https://ibn.fm/78hI3. SureNano Science is a Canadian life sciences company focused on acquiring and advancing innovative pharmaceutical and biotechnology assets. The company has acquired GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company developing GEP-44, a patented peptide targeting obesity and metabolic disorders with improved tolerability and potential non-injectable delivery. In addition to its pharmaceutical focus, SureNano Science initially engaged in the sale and distribution of the SureNano(TM) surfactant, a food-grade compound for nanoemulsions. The company holds exclusive distribution rights for this surfactant in Canada, Oklahoma, and Colorado.
For more information about SureNano Science and its developments, visit the company's newsroom at https://ibn.fm/SURNF. This announcement underscores the company's transition from a distribution business to a clinical-stage pharmaceutical entity, addressing the growing global health markets of obesity and type 2 diabetes. The initiation of FDA-aligned preclinical studies is a critical step in de-risking GEP-44 and moving toward human trials, potentially offering a new therapeutic option in a market dominated by existing GLP-1 agonists.
