On the morning of November 12, 2023 Eastern Time, USA, the results of the Phase IIa clinical trial (ClinicalTrials. gov ID: NCT04483115) of TPN171H tablets for the treatment of pulmonary arterial hypertension were announced at the 2023 (AHA Scientific Sessions) Featured Science.
This is a clinical study jointly led by Professor Yong Huo of Peking University First Hospital and Professor Zhicheng Jing of Peking Union Medical College Hospital, and jointly sponsored by Vigonvita Life Sciences Co., Ltd. and SIMM Chinese Academy of Sciences, to explore the impact of a single oral dose of TPN171H tablet on acute hemodynamics in patients with pulmonary arterial hypertension.
This study is a multicenter, randomized, double-blind, placebo, and positive control phase IIa clinical trial. A total of 60 Chinese patients with pulmonary hypertension were included in the trial, divided into 6 groups with 10 people in each group. They were respectively assigned to the placebo group, the experimental drug 2.5 mg, 5 mg, 10 mg groups, and the tadalafil 20 mg and 40 mg groups. Collect baseline hemodynamic parameters from subjects after Swan Ganz floating catheter placement to evaluate acute hemodynamic changes within 24 hours after administration.
The experimental results showed that compared to the corrected values of the placebo group, the TPN171H 5 mg group had a 16.8% decrease in pulmonary vascular resistance compared to baseline (P=0.008), indicating that it can effectively reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension; Compared with the placebo group, the TPN171H 5 mg group showed a more significant decrease in pulmonary vascular resistance/systemic circulation resistance at 2, 3, and 5 hours after administration, indicating higher pulmonary circulation selectivity.
The publication of this research result at the top academic conferences in the global cardiovascular field has verified the preliminary efficacy of TPN171H tablets in the treatment of pulmonary arterial hypertension. At present, Vigonvita Life Sciences Co., Ltd. is actively promoting clinical research on TPN171H tablets and striving to make it launched as soon as possible.