Tectonic Therapeutic announces findings from Phase Ia trial of TX45

Tectonic Therapeutic has reported positive topline results from its Phase Ia trial of TX45, a treatment for Group 2 pulmonary hypertension-heart failure with preserved ejection fraction (PH-HFpEF). The trial evaluated safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of TX45 in healthy subjects, with doses ranging from 0.3mg/kg to 3mg/kg intravenously and 150mg to 600mg subcutaneously. Results showed minimal adverse events and no immune-mediated clearance. A strong PK/PD relationship was established by measuring changes in renal plasma flow, aiding in identifying Phase II doses. Preclinical models confirmed TX45’s ability to enhance renal plasma flow. Based on these findings, Tectonic selected dosing regimens for its upcoming Phase II trial in PH-HFpEF patients, with results expected in 2026.