SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF), a Canadian life sciences company, has initiated 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 is intended to support an Investigational New Drug (IND) application, a necessary step before first-in-human clinical trials.
GEP-44 is a next-generation incretin-based therapy developed by Syracuse University, for which SureNano has secured licensing rights. The company positions itself as an agile entrant in the rapidly expanding GLP-1 market, which has seen significant growth due to the success of existing therapies. SureNano's candidate aims to offer improved tolerability and potential non-injectable delivery, differentiating it from current options.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, stated that the initiation of these FDA IND-enabling studies marks a major milestone. "Moving us firmly towards the final, rigorous evaluation in various clinical phases before entering the clinic," said Dr. Pandey. He emphasized that partnering with a globally renowned CRO like LabCorp will ensure the studies meet the highest regulatory standards, de-risking the lead candidate and supporting a strategy to launch a Phase I clinical trial in Australia.
The preclinical development program is designed to generate data on the safety and efficacy of GEP-44, addressing the growing global health burden of obesity and type 2 diabetes. According to the World Health Organization, obesity has nearly tripled since 1975, and diabetes is a leading cause of death worldwide. SureNano's candidate could provide a new therapeutic option for these patients if successful in clinical trials.
SureNano Science is transitioning from its initial business of distributing the SureNano surfactant, a nanoemulsion base for food products, into a pharmaceutical-focused company. The acquisition of GlucaPharm Inc., the developer of GEP-44, underscores this strategic shift. The company's exclusive license to distribute the surfactant in Canada and parts of the United States provides a revenue stream while it advances its pharmaceutical pipeline.
Investors can follow updates on SureNano Science's progress through its newsroom at https://ibn.fm/SURNF. The full article discussing these developments is available at https://ibn.fm/78hI3.
