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Preclinical Advancement of Novel Mechanism-of-Action Therapeutics to Combat Type 2 Diabetes in US Veterans


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The purpose of this project is to complete rigorous nonclinical studies to support an IND application submission to the US FDA for our most promising Type 2 diabetes (T2D) drug candidate. These studies encompass advanced drug metabolism and pharmacokinetic (DMPK), synthesis/process development, engineered GMP-like batch API, and GLP safety pharmacology, genotoxicity, and toxicology studies in rodents and non-rodents, with the goal to fully identify potential liabilities that might prevent our current clinical candidate drugs from achieving successful clinical endpoints. Over the first year of this project (July,2019-2020), we have successfully completed all milestones defined by our SOW including: i) process research and development, analytical method development, proof-of-concept synthesis/route optimization, and demonstration of 0.5 kg batch of our lead drug; ii) cross-species pharmacokinetic and drug metabolism characterization, dose-ranging efficacy study in obese mouse models of T2D, and dose-range finder and no observable adverse effect determination by oral dosing in rats. In addition, we have engaged with regulatory experts to set the stage for pre-IND meeting preparations. Meaningful and significant outcomes from all these activities have guided the continued advancement of our project milestones for years 2 and 3 to ultimately develop a paradigm-shifting class of drugs to improve the lives of millions of US Veterans and civilians battling T2D.



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