Tectonic Therapeutic announced that the FDA has cleared its investigational new drug, or IND, application for TX45, an Fc-relaxin fusion protein being evaluated for the treatment of patients with Group 2 PH-HFpEF. TX45 aims to address the physiological abnormalities of PH-HFpEF through its effects on both pulmonary and systemic vasodilation, cardiac diastolic dysfunction and potential remodeling in both the pulmonary vessels and cardiac muscle, which could translate into a clinically meaningful improvement in exercise capacity in these patients. Tectonic expects to initiate the global Phase 2 clinical trial of TX45 in PH-HFpEF in the third quarter of 2024, with topline results anticipated in 2026.
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