On May 17, 2025, Tectonic Therapeutic presented complete results from Part A of the Phase 1b clinical trial of TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) at the ESC Heart Failure 2025 Congress. The full cohort of 19 patients confirmed the tolerability and hemodynamic effects previously reported in interim data.
A single intravenous dose of TX45 was well tolerated, with no serious or severe adverse events, discontinuations, infusion reactions, or drug-related adverse events. In the overall study population, TX45 achieved a 19.0% reduction in pulmonary capillary wedge pressure (PCWP), and in the CpcPH subpopulation, it demonstrated a greater than 30% reduction in Pulmonary Vascular Resistance (PVR).
New hemodynamic data from the Phase 1b trial also showed sustained hemodynamic effects of TX45 out to 29 days via echocardiographic analysis. The positive and consistent hemodynamic effects across a range of Left Ventricular Ejection Fraction (LVEF) confirmed that TX45 is well positioned to address the full spectrum of PH-HFpEF patients.
These complete results continue to support the hypothesis that TX45 may provide the greatest benefit to patients with CpcPH, based on strong improvements in pulmonary hemodynamics and cardiac output relative to baseline PVR. Topline data from Part B of the Phase 1b study in PH-HFrEF patients are expected in the second half of 2025.
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