SureNano Science (CSE: SURE) (OTCQB: SURNF) is advancing its lead drug candidate GEP-44 into a critical phase of preclinical development, initiating 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. The company is positioning itself as an agile entrant in the next-generation GLP-1 landscape, having developed a patented high-performing second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound from Syracuse University.
The obesity and type 2 diabetes treatment landscape is rapidly expanding, with GLP-1 receptor agonists leading the market. SureNano's GEP-44 is a multi-receptor peptide that aims to improve tolerability and potentially allow non-injectable delivery, differentiating it from existing therapies. 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 company's focus on GEP-44 aligns with its broader strategy of acquiring and developing innovative pharmaceutical assets. SureNano Science acquired GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company, to gain access to GEP-44. Additionally, the company's initial business involves the sale and distribution of the SureNano™ surfactant, a ready-to-mix food grade compound for nanoemulsions. However, the company is transitioning to a pharmaceutical-focused entity through the advancement of GEP-44.
The GLP toxicology and pharmacology program is designed to de-risk the lead candidate and ensure compliance with FDA standards. Successful completion of these studies will enable the company to file an IND application and proceed to Phase I clinical trials. The article detailing this development can be found at https://ibn.fm/78hI3. For more information about SureNano Science, visit the company's newsroom at https://ibn.fm/SURNF.
The obesity and metabolic disease market represents a significant opportunity, with global prevalence rising. SureNano's entry with a potentially differentiated therapy could address unmet needs for improved tolerability and alternative delivery methods. The company's collaboration with LabCorp, a globally recognized contract research organization, underscores its commitment to rigorous scientific evaluation. As the company moves toward clinical-stage evaluation, investors and the medical community will be watching closely for results from these enabling studies.
