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Investing.com -- Shares of Tectonic Therapeutic, Inc. (NASDAQ: TECX) surged 40% following the announcement of encouraging interim data from a Phase 1b trial for its TX45 treatment in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF).
The Watertown-based biopharmaceutical company revealed that TX45, a long-acting Fc-relaxin fusion protein, demonstrated significant improvements in left ventricular function and pulmonary hemodynamics. These results are particularly noteworthy as they support the endpoints and patient population in the ongoing APEX Phase 2 clinical trial, with top-line results expected in 2026.
Tectonic reported that TX45 achieved a 17.9% reduction in Pulmonary Capillary Wedge Pressure (PCWP) across the study population. Moreover, in a subset of patients with more severe disease, known as Combined pre- and post-capillary Pulmonary Hypertension (CpcPH), the treatment led to a reduction in Pulmonary Vascular Resistance (PVR) by more than 30%. These hemodynamic measures are closely correlated with exercise capacity and mortality in heart failure patients.
Safety data from the trial indicated that TX45 was well tolerated with no reports of serious or severe adverse events. The interim analysis was based on 16 of the 19 enrolled patients, with the remaining three expected to complete Part A of the protocol soon.
In a statement, Dr. Alise Reicin, President and CEO of Tectonic, expressed optimism about the trial’s findings and their implications for the Phase 2 APEX trial. She noted that the improvements in hemodynamics met and exceeded the trial’s prespecified objectives and could potentially improve exercise capacity and outcomes for patients with PH-HFpEF—a group currently lacking approved treatment options.
The trial’s safety results were reassuring, with no serious adverse events or significant changes in vital signs, physical exams, or safety laboratory values post-administration of TX45. Transient asymptomatic decreases in blood pressure were the only notable observations within the first 24 hours after dosing.
The company plans to present the complete Phase 1b clinical trial results at future medical meetings, and Part B of the trial, evaluating TX45 in Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (PH-HFrEF), is set to begin enrollment in February.
Tectonic’s announcement has clearly resonated with investors, as the stock’s substantial rise reflects optimism for TX45’s potential to address a critical unmet medical need.
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