Tectonic Therapeutics Inc. (TECX), a clinical-stage biotechnology company, on Wednesday announced completion of enrollment in the Phase 2 APEX trial for TX45 in treating pulmonary hypertension associated with heart failure with preserved ejection fraction.
Pulmonary Hypertension associated with Heart Failure with preserved Ejection Fraction (PH-HFpEF) is the Group 2 subtype of pulmonary hypertension that develops due to left-sided heart disease. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart. This increased pulmonary pressure gradually causes shortness of breath and right-sided heart failure, which can lead to death.
Based on pulmonary hemodynamics, the disease may further be categorized into Isolated, post-capillary PH (IpcPH) and Combined pre- and post- capillary PH (CpcPH).
TX-45 is a long-acting Fc-relaxin fusion protein, that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, that acts as a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity.
The Phase 2 APEX trial is a global, randomized, double-blind, placebo-controlled, proof-of-concept study that enrolled 191 patients of PH-HFpEF across 14 countries, with 137 patients of CpcPH with a pulmonary vascular resistance (PVR) more than or equal to 3 Wood Units (WU) at the baseline.
The patients will be studied over 24 weeks, with cohorts dosed with a 300 mg subcutaneous injection of TX-45 in a monthly or biweekly interval, or a placebo. The primary endpoint is a change observed in PVR in patients with CpcPH.
Topline results from the Phase 2 APEX trial are expected in the first quarter of 2027.
TECX closed Wednesday at $28.05, down 1.79%.
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