NANJING, China, Dec. 16, 2019 /PRNewswire/ -- TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure.
NANJING, China, Nov. 6, 2019 / -- TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
NANJING, China, Jan. 08, 2019 TransThera Biosciences Co. Ltd, announced today the dosing of the first patient in a phase I first-in-human clinical trial of TransThera’s lead product candidate, TT-00420, for the treatment of triple negative breast cancer (TNBC) and advanced solid tumors. “We are excited to reach a milestone of advancing TT-00420 into clinical stage, and we hope that TT-00420 can transform the treatment landscape for TNBC. We are very grateful to our team, collaborators and clinical PI for fast executing the clinical development plan”, stated Dr. Frank Wu, founder and CEO of TransThera. The phase I study is a global, multicenter trial involving a dose escalation arm followed by a dose expansion arm to evaluate the safety, tolerability, and efficacy of TT-00420.