December 18, 2019 – SAN DIEGO, California
Nanjing TransThera Biosciences Co., Ltd. announced on December 16, 2019 that the U.S. Food and Drug Administration (FDA) granted the clearance of the Investigational New Drug (IND) application to proceed with the first-in-human, phase I trial of TT-00920, a phosphodiesterase (PDE9) inhibitor. This study will be conducted in adult healthy subjects to evaluate the safety, tolerability, and pharmacokinetic profile of TT-00920.
Dr. Frank Wu, founder and CEO of TransThera, said, "We believe that TT-00920 has potential to be a new transformative treatment option for patients suffering from chronic heart failure, particularly for HFpEF [heart failure with persevered ejection fraction], a predominant form of heart failure with no disease-modifying treatment options. We look forward to evaluating the potential of TT-00920 in clinic."
The IND application of TT-00920 marks the second regulatory collaboration between CRC Oncology and TransThera.
TT-00920 is a novel, potent, and highly selective PDE9 inhibitor intended for the treatment of chronic heart failure. A phase I, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose study (TT00920US01) will be conducted in healthy subjects in a single center and is anticipated to initiate in early 2020.
About TransThera Biosciences
TransThera Biosciences, founded in 2016, is a clinical-stage biotechnology company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs, including cancer, cardiovascular, and inflammatory diseases. TT-00920 marks the company's second innovative drug candidate entering global clinical development. For more information, please visit www.transtherabio.com.
About CRC Oncology
CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit www.crconc.com.