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 targeting obesity and type 2 diabetes. The program is aligned with U.S. Food and Drug Administration (FDA) requirements and represents a critical step toward filing an Investigational New Drug (IND) application, moving the company closer to first-in-human clinical trials.
The studies will assess safety, dosing thresholds, and pharmacological effects across multiple species. Preclinical results for GEP-44 position it head-to-head with established therapies such as Ozempic, Mounjaro, and Wegovy, according to the company. The program is expected to support a Phase I clinical trial in Australia, subject to regulatory submission and study outcomes.
SureNano's transition toward a pharmaceutical-focused model follows its acquisition of GlucaPharm, positioning the company in the rapidly expanding GLP market, which is projected to reach $200 billion in sales by 2030. J.P. Morgan estimates the broader incretin market could reach that figure, with approximately 25 million patients in the United States alone expected to use GLP-1 therapies by 2030.
GEP-44 is a patented second-generation incretin-based therapy developed by Syracuse University, for which SureNano secured licensing rights. The company is also exploring acquisition or licensing of Ibogaine-related intellectual property for potential mental health and addiction treatments, though no definitive agreements have been announced.
The GLP-1 receptor agonist market is experiencing rapid growth, driven by the high demand for effective obesity and diabetes treatments. SureNano, as a smaller player, aims to compete by offering a next-generation therapy that may differentiate itself from current market leaders. The company cautions that forward-looking statements, including expectations regarding market size and study outcomes, involve risks and uncertainties, and actual results may differ materially.
SureNano Science is a Canadian life sciences company focused on developing therapies for metabolic diseases. The company's news and updates are available in its newsroom at https://ibn.fm/SURNF.
