Tectonic Therapeutic has announced positive topline results from Part B of its Phase 1b clinical trial evaluating TX45 in patients with Group 2 pulmonary hypertension associated with heart failure with reduced ejection fraction (HFrEF), according to the company. The results, the company said, demonstrate favorable safety, tolerability, and pharmacodynamic outcomes that support further clinical development of the investigational therapy.
According to the company, TX45 is a first-in-class therapeutic targeting a specific G protein-coupled receptor (GPCR) implicated in pulmonary vascular remodeling and cardiac dysfunction. The Phase 1b Part B study was designed to assess safety, pharmacokinetics, and preliminary efficacy signals of TX45 in patients with elevated pulmonary vascular resistance due to left heart disease. The company said the trial met its primary and secondary endpoints, showing improvements in key hemodynamic parameters and biomarkers relevant to pulmonary hypertension progression.
Tectonic Therapeutic claims the data reinforce TX45’s potential to address an unmet need in Group 2 pulmonary hypertension, a condition with limited treatment options and high morbidity. The company added that TX45 was well tolerated across all tested doses, with no drug-related serious adverse events reported.
The company said it plans to advance TX45 into a Phase 2 clinical trial to further evaluate its safety and efficacy in a larger patient population. Tectonic Therapeutic also noted that additional data from the ongoing analyses will be presented at an upcoming medical conference.
