Tectonic has completed enrollment in the APEX 24-week Phase 2 trial evaluating TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), according to the company.
The randomized, double-blind, placebo-controlled study enrolled 191 patients across 14 countries and was designed to enrich for the combined pre- and post-capillary pulmonary hypertension subgroup (CpcPH) with pulmonary vascular resistance greater than 3 Wood Units; 137 patients met that threshold, representing about 72 percent of the cohort.
Patients were randomized to receive 300 mg subcutaneous TX45 once monthly, 300 mg every other week, or placebo, with change from baseline in PVR in the PVR>3 WU population as the primary endpoint.
The company reports a mean baseline PVR of 4.2 WU in the overall population and 5.2 WU in the CpcPH subset and notes that those baseline characteristics are preliminary.
TX45 is an Fc-relaxin fusion protein that activates the RXFP1 receptor and is intended to produce vasodilatory, anti-fibrotic and anti-inflammatory effects. Topline results are expected in early Q1 2027.
