Tectonic Therapeutics Inc. (TECX) has reported promising topline results from its Phase 1a trial of TX45, a long-acting relaxin candidate aimed at treating Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF).
The Phase 1a trial, a single ascending dose study, assessed the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of TX45, leveraging relaxin's known capacity to enhance renal plasma flow. The study tested intravenous (IV) doses of 0.3, 1, and 3 mg/kg and subcutaneous (SC) doses of 150, 300, and 600 mg in healthy volunteers. Results demonstrated minimal adverse events and no signs of immune-mediated clearance for TX45.
Tectonic Therapeutics highlighted that the topline Phase 1a results corroborate the preliminary data obtained at lower doses. The findings also underscore the effective translation of robust preclinical models into clinical settings, enabling the company to select appropriate doses for its upcoming global Phase 2 randomized, six-month trial. This next phase will evaluate the impact of TX45 on PH-HFpEF patients, with a focus on those experiencing combined pre- and post-capillary PH.
