Tectonic Therapeutic Reports Positive Interim TX45 Phase 1b Trial Data

January 30, 2025

DENVER, Colo., Jan 30, 2025 (247marketnews.com)- Tectonic Therapeutic (NASDAQ: TECX) released positive interim data from their TX45 Phase 1b trial. TX45 showed promise for patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF). The interim results show that TX45, a long-acting Fc-relaxin fusion protein, has the potential to improve both left ventricular function and pulmonary hemodynamics—critical factors for managing this complex condition.

Alise Reicin, M.D., Tectonic’s President and CEO, commented, “These interim results show that TX45 achieved improvements in hemodynamics which met and exceeded our prespecified objectives. We are highly encouraged that TX45 improved left ventricular function and pulmonary hemodynamics, because we believe improving both parameters is necessary to improve exercise capacity and outcomes in patients with pulmonary hypertension with HFpEF. We believe these Phase 1b interim data accelerate momentum of our TX45 clinical program as our ongoing Phase 2 APEX trial is designed to enroll a similar patient population and evaluate the same endpoints. These data strengthen our confidence in advancing TX45 for the many patients with PH-HFpEF who face high mortality and have no currently approved treatments.”

The data points to meaningful hemodynamic improvements, including a significant reduction in Pulmonary Capillary Wedge Pressure (PCWP) by 17.9% in the overall study population, which correlates with better exercise capacity and potentially improved outcomes for these patients. Even more encouraging is the >30% reduction in Pulmonary Vascular Resistance (PVR) in the subset of patients with more severe disease (Combined pre- and post-capillary PH, or CpcPH). This suggests that TX45 could provide targeted benefits for those with more severe disease, a population currently lacking effective treatments.

Marcella K. Ruddy, M.D., Tectonic’s CMO, added, “We are particularly encouraged by the striking results in CpcPH patients who saw improvements in both PCWP and PVR. This finding suggests that these patients, who have more severe disease, may have the greatest benefit from a relaxin therapeutic. These data support our planned enrichment of CpcPH patients in our Phase 2 APEX trial.

TX45’s safety profile seems favorable, with no serious adverse events reported, and may be well tolerated by patients with PH-HFpEF. These results are likely to fuel optimism about the drug’s potential in treating this underserved patient population.

The ongoing APEX Phase 2 trial, which is designed to evaluate TX45 further in a similar patient group, will likely provide more clarity. The positive interim results from the Phase 1b trial help build confidence in TX45’s therapeutic potential and support its continued development.

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