SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) is advancing its lead drug candidate GEP-44 into a critical preclinical phase designed to support an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The company has initiated a Good Laboratory Practice (GLP) toxicology and pharmacology program, a necessary step before first-in-human clinical trials. This development marks a transition from preclinical research toward clinical-stage evaluation for the multi-receptor peptide targeting obesity and type 2 diabetes.
GEP-44 is a patented second-generation incretin-based therapy that SureNano acquired licensing rights for from Syracuse University. The compound is designed to improve upon existing GLP-1 receptor agonists by potentially offering better tolerability and non-injectable delivery options. According to the company, the GLP market is expanding rapidly, and SureNano aims to position itself as an agile entrant in the next-generation GLP-1 landscape.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, emphasized the importance of the IND-enabling studies. "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 preclinical program is intended to generate data on the safety and efficacy of GEP-44, which will be crucial for regulatory approval and subsequent human trials. Obesity and metabolic disorders represent a significant global health challenge, with millions affected worldwide. Current treatments often require injections and can cause side effects, so a therapy with improved tolerability and alternative delivery methods could address a substantial unmet need.
SureNano Science, through its subsidiary GlucaPharm Inc., is focused on developing GEP-44 for obesity and metabolic diseases. The company also has an existing business selling the SureNano(TM) surfactant, a food-grade compound used for creating nanoemulsions. However, the pharmaceutical development of GEP-44 represents a strategic shift toward becoming a clinical-stage biotechnology company.
For more details, the full article can be accessed at https://ibn.fm/78hI3. Additional information about SureNano Science is available in the company's newsroom at https://ibn.fm/SURNF.
