Clinical Read2026-06-10

TX45 - (APEX)

Tectonic Therapeutic Inc.TECX
Indication
Group 2 Pulmonary Hypertension
Stage
phase2
Event
Topline Data
Details

June 10, 2026: Tectonic Therapeutic, Inc. (NASDAQ: TECX) announced completion of enrollment for APEX, a 24-week, global, randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial evaluating TX45 in pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), enriched for the more severe combined pre- and post-capillary pulmonary hypertension (CpcPH) subtype. APEX enrolled 191 patients across 14 countries; 137 patients (~72%) were in the enriched CpcPH population with pulmonary vascular resistance (PVR) >3 Wood Units (WU) at baseline. Preliminary mean baseline PVR was 4.2 WU overall and 5.2 WU in the CpcPH/PVR>3 WU subset. Patients were randomized to TX45 300 mg subcutaneous once monthly, TX45 300 mg subcutaneous every other week, or placebo. The primary endpoint is change from baseline in PVR in the PVR>3 WU population. Topline results are expected in early Q1 2027.