Core Insights - Tectonic Therapeutic, Inc. announced positive interim data from the Phase 1b clinical trial of TX45, showing significant improvements in left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) [1][6][8] Group 1: Clinical Trial Results - TX45 achieved a 17.9% reduction in pulmonary capillary wedge pressure (PCWP) in the overall study population, which correlates with exercise capacity, morbidity, and mortality in heart failure patients [2][6][14] - In patients with combined pre- and post-capillary pulmonary hypertension (CpcPH), TX45 demonstrated over a 30% reduction in pulmonary vascular resistance (PVR), indicating a significant improvement in a more severe disease subgroup [2][9][14] - The trial enrolled 16 out of 19 patients, with 9 patients having CpcPH, and evaluated hemodynamic endpoints similar to the ongoing APEX Phase 2 clinical trial [4][10] Group 2: Safety and Tolerability - TX45 was well tolerated, with no serious or severe adverse events reported, and no significant changes in vital signs or safety laboratory values observed [5][7][9] - Transient asymptomatic decreases in blood pressure were noted within the first 24 hours post-dosing, but no clinically significant issues arose [7][9] Group 3: Future Prospects - The interim results are expected to accelerate the clinical program for TX45, with topline results from the ongoing APEX Phase 2 trial anticipated in 2026 [3][10] - The company plans to enrich the Phase 2 trial with CpcPH patients, who may benefit the most from TX45 based on the interim findings [9][12] Group 4: Product Overview - TX45 is a long-acting Fc-relaxin fusion protein that activates the RXFP1 receptor, showing potential as a therapeutic option for patients with PH-HFpEF, a condition currently lacking approved treatments [13][16] - The unique mechanism of TX45 improves both left ventricular function and pulmonary hemodynamics, differentiating it from other pulmonary arterial hypertension (PAH) drugs [8][14]
Tectonic Therapeutic Announces Positive Interim Data from Phase 1b Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF