- Tectonic Therapeutic (TECX, Financial) reports complete results from Phase 1b trial for TX45, showing significant positive outcomes in pulmonary hypertension treatment.
- The trial showed a 19.0% reduction in pulmonary capillary wedge pressure and >30% reduction in Pulmonary Vascular Resistance in CpcPH patients.
- TX45 demonstrates an 18.5% increase in cardiac output with sustained effects for 29 days post-treatment.
Tectonic Therapeutic (TECX), an organization specializing in the development of therapeutic proteins, has announced the successful completion of its Phase 1b clinical trial for TX45, a long-acting relaxin therapy. The trial targeted patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF) and involved 19 participants. These results were presented at the ESC Heart Failure 2025 Congress in Belgrade, Serbia.
The findings from the trial revealed that TX45 was well-tolerated, with no serious or severe adverse events reported. One of the significant outcomes was a 19.0% reduction in pulmonary capillary wedge pressure, an indicator of morbidity and mortality in heart failure patients. Additionally, the medication led to a >30% reduction in Pulmonary Vascular Resistance in patients suffering from combined pre- and post-capillary pulmonary hypertension (CpcPH), who generally experience more severe disease forms.
Echocardiogram data indicated sustained hemodynamic improvements for up to 29 days after a single dose, marking a clinically meaningful duration of effect. Improvements in cardiac output and pulmonary hemodynamics were noted across a range of left ventricular ejection fractions (LVEF), including LVEF ≥50% and LVEF 41-49%, further demonstrating TX45's potential broad applicability.
TX45's mechanism, leveraging the therapeutic properties of relaxin, offers a differentiated approach by not just acting as a pulmonary vasodilator but also improving left ventricular function. This positions TX45 as a promising candidate for addressing the complex pathophysiology of PH-HFpEF, particularly benefiting CpcPH patients.
Tectonic anticipates topline data from Part B of the Phase 1b study in patients with Heart Failure with reduced Ejection Fraction (HFrEF) in the second half of 2025. Looking ahead, results from the APEX Phase 2 trial are expected in 2026, potentially validating these findings in a larger patient cohort.
