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. This 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 move comes as the GLP-1 market rapidly expands, with SureNano positioning itself as an agile entrant in the next-generation GLP-1 landscape. The company has developed a patented second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound from Syracuse University. The candidate is designed with improved tolerability and potential for non-injectable delivery, addressing key limitations of current therapies.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, highlighted 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.”
SureNano Science, through its acquisition of GlucaPharm Inc., is developing GEP-44 as a patented peptide targeting obesity and metabolic disorders. The company also maintains a legacy business in the sale and distribution of the SureNano™ surfactant, a food-grade compound for nanoemulsions. However, the focus is shifting toward pharmaceutical development as the company advances GEP-44 toward the clinic.
The implications of this announcement are significant for the obesity and diabetes treatment landscape. Current GLP-1 receptor agonists, such as semaglutide, have shown high efficacy but often require injectable administration and can cause gastrointestinal side effects. GEP-44, as a multi-receptor peptide, may offer improved tolerability and the possibility of non-injectable delivery, potentially expanding patient access and adherence. If successful, it could capture a substantial share of the growing GLP-1 market, projected to reach tens of billions of dollars in the coming years.
Investors should note that the initiation of GLP studies represents a critical de-risking step. Successful completion of these studies and subsequent IND approval would pave the way for Phase I trials, providing clearer valuation catalysts. The company’s strategy to launch a Phase I trial in Australia, known for its efficient regulatory environment, could accelerate timelines. However, the candidate remains in preclinical stages, and significant regulatory, clinical, and commercial risks persist.
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