Tectonic Enrolls 191 Patients in Phase 2 TX45 Trial for PH-HFpEF
TECX•Tectonic Therapeutic has fully enrolled 191 patients across 14 countries in its 24-week APEX Phase 2 trial evaluating safety and efficacy of TX45 in PH-HFpEF patients, with 137 individuals (72%) having CpcPH and baseline PVR >3 WU. Topline APEX results are expected in early Q1 2027.
1. Enrollment Milestone Achieved
The APEX trial has reached full enrollment with 191 patients across 14 countries, including 137 individuals (72%) with combined pre- and post-capillary PH (CpcPH) and baseline pulmonary vascular resistance (PVR) above 3 Wood Units, aligning with the study’s enrichment target.
2. Trial Design and Endpoints
APEX is a 24-week, randomized, double-blind, placebo-controlled Phase 2 study assessing two TX45 dosing regimens—300 mg subcutaneous monthly and 300 mg subcutaneous every other week—against placebo, with change from baseline PVR in the PVR >3 WU population as the primary endpoint.
3. TX45 Mechanism and Therapeutic Profile
TX45 is an Fc-relaxin fusion protein engineered for optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor to induce vasodilation, anti-fibrotic and anti-inflammatory effects aimed at reducing pulmonary resistance in PH-HFpEF patients.
4. Upcoming Data Readout
With enrollment complete, Tectonic anticipates APEX topline data in early Q1 2027, a pivotal readout that will inform the therapeutic profile of TX45 and shape subsequent development and regulatory strategy.
