SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) announced the initiation of a Good Laboratory Practice (GLP) toxicology and pharmacology program for its lead drug candidate GEP-44, a multi-receptor peptide targeting obesity and type 2 diabetes. The program is designed to meet U.S. Food and Drug Administration (FDA) requirements and support an Investigational New Drug (IND) application, a necessary step before first-in-human clinical trials.
The company, which has acquired GlucaPharm Inc., is positioning itself as an agile entrant in the rapidly expanding next-generation GLP-1 landscape. GEP-44 is a patented high-performing second-generation incretin-based therapy, developed at Syracuse University and licensed by SureNano. The drug candidate offers a novel multi-receptor approach that may improve upon existing GLP-1-based therapies, potentially offering better tolerability and non-injectable delivery options.
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 implications of this development are significant given the global obesity and diabetes epidemics. GEP-44, as a multi-receptor peptide, offers a novel approach that may improve upon existing GLP-1-based therapies. The initiation of FDA-compliant studies demonstrates progress toward clinical validation and potential market entry. For more details, the full article can be accessed at https://ibn.fm/78hI3.
SureNano Science's initial business involved 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 company through the advancement of this therapeutic candidate. The company's latest news and updates are available in the company's newsroom at https://ibn.fm/SURNF.
