SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) has announced the initiation of a Good Laboratory Practice (GLP) toxicology and pharmacology program for its lead drug candidate GEP-44, a multi-receptor peptide designed to treat obesity and type 2 diabetes. The program aligns with U.S. Food and Drug Administration (FDA) requirements and is intended to support an Investigational New Drug (IND) application, a necessary step before first-in-human clinical trials.
The company, which recently acquired GlucaPharm Inc., is positioning itself as an agile entrant in the rapidly expanding GLP-1 market. GEP-44 is a patented second-generation incretin-based therapy developed by Syracuse University and licensed by SureNano. The compound targets multiple receptors, potentially offering improved tolerability and non-injectable delivery options compared to existing therapies.
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 GLP program is a critical step in drug development, providing data on safety and pharmacokinetics required for regulatory approval. Success could pave the way for SureNano to enter clinical trials, potentially offering a new treatment option for obesity and type 2 diabetes, conditions affecting millions worldwide. The global GLP-1 receptor agonist market is expanding rapidly, with increasing demand for more effective and tolerable therapies.
SureNano Science is transitioning from its initial business of distributing the SureNano(TM) surfactant into a pharmaceutical-focused company. The surfactant, a food-grade nanoemulsion base, is used in various industries for its ability to create stable, homogeneous products. The company holds exclusive distribution rights for the surfactant in Canada, Oklahoma, and Colorado.
The announcement underscores the company's commitment to advancing its pipeline and addressing large global health markets. For more details, the full article is available at https://ibn.fm/78hI3. Further updates on SureNano Science can be found in the company's newsroom at https://ibn.fm/SURNF.
