ROCKVILLE, MD – Tasly Pharmaceuticals, Inc. announced the presentation of Phase III clinical trial results for its investigational botanical drug candidate T89 (Dantonic®) at the American College of Cardiology (ACC) 67th Annual Scientific Session held on March 12, 2018, in Orlando, Florida.
The multi-center, randomized, double-blind, placebo-controlled Phase III study evaluated T89 in patients with chronic stable angina. Results indicated statistically significant improvements in Treadmill Exercise Duration (TED) and reductions in the frequency of angina episodes, with a safety and tolerability profile comparable across treatment groups.
The study was conducted in accordance with U.S. Food and Drug Administration (FDA) regulatory standards, International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and applicable regional regulatory requirements. The trial enrolled patients across 137 clinical sites in multiple countries, including the United States, Canada, Mexico, Georgia, the Russian Federation, and Ukraine, between July 2012 and March 2016.
T89 is among multi-component botanical drug candidates that have completed an FDA-regulated global Phase III clinical program, supporting the continued evaluation of botanical therapeutics within modern drug development frameworks.
Data presented at ACC further indicated improvements in exercise tolerance and reductions in angina frequency compared to placebo. Safety findings were generally comparable across treatment groups, with no clinically meaningful increase in adverse events observed.
The study also demonstrated batch-to-batch consistency in clinical outcomes, supporting the robustness of Tasly’s manufacturing controls, quality systems, and adherence to current Good Manufacturing Practice (cGMP) requirements for botanical drug products.
T89 (Dantonic®) is a standardized botanical formulation manufactured using validated processes to ensure identity, purity, potency, and consistency in accordance with regulatory expectations for complex botanical products. The product has prior commercialization experience in international markets and is currently under development in the United States as T89.
The clinical program reflects accumulated global experience in the evaluation of this formulation.
Tasly Pharmaceuticals, Inc. continues to advance its botanical drug development platform through the integration of traditional medical knowledge with modern regulatory science, clinical evaluation, and pharmaceutical quality systems.