SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) is entering a critical phase of preclinical development for its lead drug candidate GEP-44, a multi-receptor peptide designed to treat obesity and type 2 diabetes. The company announced the initiation of a Good Laboratory Practice (GLP) toxicology and pharmacology program aligned with U.S. Food and Drug Administration (FDA) requirements, a necessary step before filing an Investigational New Drug (IND) application and advancing to first-in-human clinical trials.
According to the announcement, the program is being conducted in partnership with LabCorp, a globally recognized contract research organization (CRO). This collaboration ensures that studies meet the highest regulatory standards, de-risking the candidate and supporting the company's strategy to launch a Phase I clinical trial in Australia. SureNano acquired the licensing rights to GEP-44 from Syracuse University and has developed it as a high-performing second-generation incretin-based therapy.
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.” He added that partnering with a globally renowned CRO like LabCorp will ensure the studies meet stringent regulatory standards.
SureNano Science is a Canadian life sciences company focused on acquiring and advancing pharmaceutical and biotechnology assets targeting large global health markets. The company recently acquired GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company developing GEP-44, a patented peptide for obesity and metabolic disorders with improved tolerability and potential for non-injectable delivery.
The company’s initial business involves the sale and distribution of the SureNano(TM) surfactant, a ready-to-mix food grade compound for nanoemulsions, but it is now transitioning into a pharmaceutical-focused entity. The advancement of GEP-44 represents a strategic shift toward addressing obesity and metabolic disease, markets that are rapidly expanding with the success of GLP-1 agonists.
The full article detailing this development is available at https://ibn.fm/78hI3. For more information about SureNano Science, visit the company’s newsroom at https://ibn.fm/SURNF.
