Tectonic Therapeutic (NASDAQ:TECX) has announced positive interim data from its Phase 1b acute hemodynamic clinical trial of TX45 in Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”).
The company reports that TX45 was well tolerated with the overall study population achieving a 17.9% reduction in pulmonary capillary wedge pressure (PCWP), an endpoint known to correlate with exercise capacity, morbidity, and mortality in patients with heart failure.
In a statement, Alise Reicin, MD, president and CEO of Tectonic, commented, “These interim results show that TX45 achieved improvements in hemodynamics which met and exceeded our prespecified objectives. We are highly encouraged that TX45 improved left ventricular function and pulmonary hemodynamics, because we believe improving both parameters is necessary to improve exercise capacity and outcomes in patients with pulmonary hypertension with HFpEF.”
“We believe these Phase 1b interim data accelerate momentum of our TX45 clinical program as our ongoing Phase 2 APEX trial is designed to enroll a similar patient population and evaluate the same endpoints. These data strengthen our confidence in advancing TX45 for the many patients with PH-HFpEF who face high mortality and have no currently approved treatments,” Dr. Reicin added.
