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SureNano Science Initiates FDA Stage GLP Toxicology and Pharmacology Studies for GLP GEP-44 and Enters Discussions to Acquire Ibogaine Formulation IP Portfolio
GLP-compliant program covering rodents, non-rodents, and primates will define safety, MTD and safe dose ranges, targeting weight loss and TIIDMNovel Ibogaine formulation development for mental health treatment including addiction Studies support upcoming regulatory submission and initiation of Phase I trial in AustraliaVancouver, British Columbia--(Newsfile Corp. - April 24, 2026) - SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) ("SureNano" or the "Company"), parent company of GlucaPharm Inc..
About this update from Surenano Science Ltd
Vancouver, British Columbia--(Newsfile Corp. - April 24, 2026) - SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) ("SureNano" or the "Company"), parent company of GlucaPharm Inc. ("GlucaPharm"), a biopharmaceutical company developing novel therapeutic multi-receptor GLP-1 agonist peptide for the treatment of Type II Diabetes and Obesity candidates, today announced the planning of a comprehensive U.S. Food and Drug Administration (FDA) pathway Investigational New Drug (IND)-enabling Good Laboratory Practice (GLP) toxicology and pharmacology study program for its lead candidate GEP-44 (the "Program"). The Program is expected to be conducted in collaboration with a premier global Clinical Research Organization (CRO), LabCorp, known for its expertise in preclinical development, subject to entering into definitive collaboration agreements and the funding of related amounts. This pivotal, GLP-compliant package is specifically designed to assess safety, toxicology, and pharmacology across multiple species, including rodents and non-rodent primates, to evaluate the safety and feasibility of the approach for human clinical application. The studies will provide comprehensive data to determine the maximum tolerated dose (MTD), identify potential biomarkers for monitoring toxicity, assess the reversibility of toxic effects, and establish the safety margin needed for first-in-human studies. "Initiating these U.S. Food and Drug Administration (FDA) 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 Nihar Pandey, PhD., Chief Scientific Officer at SureNano. "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." Following the successful completion of these studies, SureNano intends to submit a Clinical Trial Notification (CTN) in Australia to begin U.S. Food and Drug Administration (FDA) Phase I testing in patients. Australia is chosen for its efficient regulatory framework, high-quality research infrastructure, and accelerated path to first-in-human studies. With the...
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