Preclinical Advancement of Novel Mechanism-of-Action Therapeutics to Combat Type 2 Diabetes in US Veterans
Abstract
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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2020
- Accession Number
- AD1112054
Entities
People
- Harshini Neelakantan