Tectonic Therapeutic Completes Phase 2 Trial Enrollment

By Greg Peters • Thursday, June 11 16:54 • Permanent Link

Tectonic Therapeutic said it has completed enrollment in its 24-week Phase 2 APEX trial of TX45 in pulmonary hypertension associated with heart failure with preserved ejection fraction, or PH-HFpEF.

The study enrolled 191 patients across 14 countries. Of those, 137 patients, or about 72%, were in the enriched combined pre* and post-capillary pulmonary hypertension group with pulmonary vascular resistance above 3 wood units at baseline. The company had targeted that subgroup to make up about 70% of the trial population.

Baseline pulmonary vascular resistance in the full study population was 4.2 wood units, while the enriched subgroup averaged 5.2 wood units.

APEX is testing two TX45 dosing regimens: 300 mg once monthly and 300 mg every other week, both given subcutaneously, against placebo. The primary endpoint is change from baseline in pulmonary vascular resistance in the PVR>3 wood units population.

Tectonic said topline results are expected in early first quarter 2027. Following these announcements, the company's shares moved 5.4%, and are now trading at a price of $29.565. Check out the company's full 8-K submission here.

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