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. This program is intended to support an Investigational New Drug (IND) application and represents a necessary step before first-in-human clinical trials.
GEP-44 is a patented second-generation incretin-based therapy developed by Syracuse University, for which SureNano has secured licensing rights. The compound is designed to improve upon existing GLP-1 receptor agonists, which have become a rapidly expanding market for weight loss and diabetes management. SureNano is positioning itself as an agile entrant in this next-generation GLP-1 landscape.
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 decision to conduct the toxicology and pharmacology program in partnership with LabCorp, a leading contract research organization, is intended to ensure that studies meet rigorous regulatory standards. The successful completion of these studies is expected to de-risk the candidate and pave the way for clinical development.
SureNano Science acquired GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company, as part of its strategy to focus on metabolic disorders. GEP-44 is being developed with the potential for improved tolerability and non-injectable delivery, which could address significant patient needs in the obesity and diabetes markets. The global prevalence of obesity and type 2 diabetes continues to rise, creating a substantial demand for effective and tolerable therapies.
In addition to its pharmaceutical pipeline, SureNano Science initially focused on the sale and distribution of the SureNano™ surfactant, a ready-to-mix food grade compound for nanoemulsions. The company holds exclusive distribution rights for the surfactant in Canada, Oklahoma, and Colorado. However, the company is now transitioning to a pharmaceutical-focused model through the advancement of GEP-44.
The initiation of these IND-enabling studies is a key step that could accelerate the timeline toward clinical trials. If successful, GEP-44 could offer a new treatment option for patients with obesity and type 2 diabetes, potentially offering advantages over current therapies. The company’s strategy to launch a Phase I trial in Australia reflects a pragmatic approach to early clinical development, given the country's efficient regulatory pathway.
For more information, visit the company’s newsroom at https://ibn.fm/SURNF.
