SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) has initiated a critical 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 announced the start of a Good Laboratory Practice (GLP) toxicology and pharmacology program that aligns with U.S. Food and Drug Administration (FDA) requirements, a necessary step before submitting an Investigational New Drug (IND) application and advancing to first-in-human clinical trials.
GEP-44 represents a next-generation incretin-based therapy, developed by Syracuse University and licensed by SureNano. The compound targets multiple receptors involved in metabolic regulation, potentially offering improved efficacy and tolerability compared to existing treatments. The global GLP-1 market has seen rapid expansion, driven by the success of drugs like Ozempic and Wegovy, and SureNano aims to position itself as an agile player in this competitive 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. He added that partnering with a globally renowned contract research organization (CRO) like LabCorp will ensure the 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 as the obesity and diabetes treatment market continues to grow, with increasing demand for more effective and convenient therapies. SureNano’s approach includes exploring non-injectable delivery methods, which could differentiate GEP-44 from current injectable GLP-1 agonists. The company holds a patent for the compound and has secured licensing rights through its acquisition of GlucaPharm Inc., a next-generation GLP-1 pharmaceutical company.
SureNano Science is also involved in the sale and distribution of the SureNano surfactant, a food-grade compound used for creating nanoemulsions in various industries. However, the company is transitioning into a pharmaceutical-focused entity, with GEP-44 as its primary asset. The IND-enabling studies are expected to de-risk the candidate and support regulatory submissions in multiple jurisdictions.
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.
