SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) has begun a critical phase of preclinical development for its lead drug candidate GEP-44, a multi-receptor peptide targeting obesity and type 2 diabetes. The company announced the initiation of a Good Laboratory Practice (GLP) toxicology and pharmacology program aligned with U.S. Food and Drug Administration (FDA) requirements, intended to support an Investigational New Drug (IND) application. This program represents a necessary step before first-in-human clinical trials can proceed.
According to the company, the move positions SureNano as an agile entrant in the rapidly expanding GLP-1 market. The company has developed a patented second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound developed by Syracuse University. The GLP-1 market is experiencing significant growth as demand for effective obesity and diabetes treatments rises.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, emphasized the importance 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 company's focus on GEP-44 comes amid a backdrop of rising obesity rates worldwide, creating a large and growing market for treatments that offer improved tolerability and potential non-injectable delivery. SureNano's acquisition of GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company, has strengthened its pipeline in metabolic disorders. The initial business of SureNano Science involved the sale and distribution of the SureNano surfactant, but the company is now pivoting to become a pharmaceutical-focused entity through the advancement of GEP-44.
By advancing GEP-44 through FDA-required studies, SureNano aims to de-risk its lead candidate and position itself for clinical testing. Successful completion of these studies could pave the way for Phase I trials, bringing the company closer to offering a new treatment option for patients with obesity and type 2 diabetes. The implications for the industry are significant, as GEP-44 could challenge existing GLP-1 therapies if it demonstrates improved efficacy and tolerability.
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