NEW YORK--(BUSINESS WIRE)--Applied Therapeutics Inc., a privately-held biotechnology company focused on developing transformative drugs in areas of high unmet medical need, today announced initiation of a Phase 1 clinical trial for AT-001, an oral small molecule in development for diabetic complications.
The Phase 1 clinical trial is a first-in-human, randomized, placebo-controlled, dose escalation study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of AT-001 in patients with Type 2 Diabetes. The study will also evaluate a specific biomarker to assess patient response.
“Initiation of this study represents a significant milestone for Applied Therapeutics, as we advance our first compound, AT-001, into the clinic,” said Shoshana Shendelman, Ph.D., Founder, Chairman and CEO of Applied Therapeutics. “We are excited to bring our therapy one step closer to patients.”
“The rapid movement from translational research to the clinic is a model of academic research collaboration and focused biotech development. We are pleased to see our work making its way to patients quickly, and we hope that AT-001 will transform the treatment of diabetic complications as a safe and efficacious therapy,” stated Donald Landry, M.D., Ph.D., Chairman of the Department of Medicine at Columbia Medical Center and Chairman of the Applied Therapeutics Scientific Advisory Board.
About Applied Therapeutics Inc.
Applied Therapeutics is a privately held biotechnology company, focused on developing transformative drugs in areas of high unmet medical need – fatal or debilitating diseases for which no therapies are approved. The company applies cutting-edge technology to validated drug targets that have failed to produce meaningful therapies in the past. Applied Therapeutics believes that through innovative science, millions of lives can be saved. For more information, visit www.appliedtherapeutics.com.