SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) has announced the initiation of a key phase of preclinical development for its lead drug candidate GEP-44, a multi-receptor peptide designed to treat obesity and type 2 diabetes. The company is launching 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 represents a necessary step before first-in-human clinical trials.
Against a backdrop of a rapidly expanding GLP-1 market, SureNano is positioning itself as an agile entrant in the next-generation GLP-1 landscape. The company has developed a patented high-performing second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound developed by Syracuse University. Dr. Nihar Pandey, Chief Scientific Officer at SureNano, emphasized 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.”
The GLP-1 market has seen substantial growth due to the success of existing therapies, but SureNano’s GEP-44 aims to differentiate itself through improved tolerability and potential non-injectable delivery. The compound targets multiple receptors, which may offer enhanced efficacy and fewer side effects compared to single-receptor agonists. SureNano’s acquisition of GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company, has been central to this development. The company’s broader strategy includes advancing GEP-44 through preclinical and clinical stages while maintaining its existing business in the sale and distribution of the SureNano surfactant, a food-grade compound used for nanoemulsions in various industries.
The importance of this announcement lies in the progression of GEP-44 from early research to regulated preclinical testing. Successful completion of these GLP studies could lead to an IND filing and subsequent clinical trials, potentially offering a new treatment option for the millions affected by obesity and type 2 diabetes. The partnership with LabCorp, a globally recognized contract research organization, adds credibility to the development process and increases the likelihood of meeting regulatory standards. For investors, this milestone de-risks the candidate and signals a transition toward clinical-stage evaluation, which could enhance the company’s valuation and market position.
For more details, the full article is available at https://ibn.fm/78hI3. Additional information and updates on SureNano Science can be found in the company’s newsroom at https://ibn.fm/SURNF.
