SureNano Science Ltd. announced it is planning comprehensive U.S. Food and Drug Administration (FDA) pathway Investigational New Drug (IND)-enabling Good Laboratory Practice (GLP) toxicology and pharmacology studies for its lead candidate GEP-44. The studies, expected to be conducted in collaboration with LabCorp, a premier global Clinical Research Organization, will assess safety, toxicology, and pharmacology across multiple species, including rodents and non-rodent primates. The program is designed to evaluate the safety and feasibility of the approach for human clinical application and will determine the maximum tolerated dose, identify potential biomarkers for monitoring toxicity, assess the reversibility of toxic effects, and establish the safety margin needed for first-in-human studies.
Lead Candidate Development
GEP-44 is a novel, patented peptide developed by researchers at Syracuse University, described as similar in function to Ozempic, Wegovy, and Mounjaro, targeting comparable or superior efficacy with improved patient tolerability and delivery potential. Following successful completion of the studies, SureNano intends to submit a Clinical Trial Notification (CTN) in Australia to begin FDA Phase I testing in patients. Australia was chosen for its efficient regulatory framework, high-quality research infrastructure, and accelerated path to first-in-human studies.
Ibogaine Portfolio Addition
U.S. President Donald Trump recently signed an Executive Order designed to fast-track research on and access to psychedelic drugs with a focus on Ibogaine, including a $50 million investment in state governments to study how psychedelics might help people struggling with mental health illnesses. The FDA also issued Investigational New Drug (IND) clearance for Ibogaine to allow for human testing for the first time in the United States. SureNano has initiated discussions with academic institutions and independent research groups to evaluate opportunities to license or acquire intellectual property related to the synthesis, formulation, and delivery of Ibogaine and structurally related compounds. The company believes Ibogaine and next-generation Ibogaine analogues have demonstrated potential in addressing addiction and mental health disorders, including opioid dependence and PTSD symptoms.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1111027620/Surenano-Science-Initiates-FDA-Stage-GLP-Toxicology-And-Pharmacology-Studies-For-GLP-GEP-44-And-Enters-Discussions-To-Acquire-Ibogaine-Formulation-IP-Portfolio