Tectonic Therapeutic Announces Positive Interim Data from Phase 1b Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF

• TX45 improved both left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”), supporting endpoints and patient population in ongoing APEX Phase 2 clinical trial
• Interim analysis demonstrated that TX45 achieved 17.9% reduction in Pulmonary Capillary Wedge Pressure (“PCWP”) in the total study population of PH-HFpEF and >30% reduction in Pulmonary Vascular Resistance (“PVR”) in Combined pre- and post-capillary PH (“CpcPH”), a subpopulation with more severe disease
• TX45 was well tolerated in patients with PH-HFpEF with no serious or severe adverse events, significant hypotension, or immune related reactions

Excerpt from the Press Release:

WATERTOWN, Mass., Jan. 30, 2025 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), today announced positive interim data from the Phase 1b acute hemodynamic clinical trial of its lead product candidate, TX45, a long-acting, Fc-relaxin fusion protein. The interim data showed that a single intravenous dose of TX45 resulted in meaningful improvements in both left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”). In the trial, TX45 was well tolerated in patients with PH-HFpEF with no serious or severe adverse events.

In the overall study population, TX45 achieved a 17.9% reduction in pulmonary capillary wedge pressure (“PCWP”), an endpoint known to correlate with exercise capacity, morbidity and mortality in patients with heart failure. In the subpopulation with combined pre- and post-capillary pulmonary hypertension (“CpcPH”) who have an elevated Pulmonary Vascular Resistance (“PVR”) and more severe disease, TX45 demonstrated >30% reduction in PVR, which along with PCWP is correlated to exercise capacity and mortality in these patients. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to our ongoing APEX Phase 2 clinical trial (ClinicalTrials.gov NCT06616974). APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026.

“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,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “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.”

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