Tectonic Therapeutic receives FDA IND clearance for lead program TX45 in PH-HFpEF

Tectonic Therapeutic, Inc.

FDA cleared IND for TX45 (Fc-relaxin fusion) for Group 2 PH due to HFpEF, a condition with no approved therapy affecting >600K US patients.
Phase 1a healthy volunteer topline results due September 2024; Phase 1b patient hemodynamic topline results expected mid-2025.
Phase 2 trial to start Q3 2024: 24-week SC dosing, up to 180 subjects; primary endpoint PVR change. Topline results anticipated in 2026.
TX45 engineered for optimized pharmacology targeting vasodilation, diastolic dysfunction, and remodeling to improve exercise capacity.

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