Tectonic Therapeutic Gets U.S. FDA IND Clearance For Lead Program, TX45

Author: Benzinga Newsdesk | July 30, 2024 04:22pm

• TX45 is an Fc-relaxin fusion protein being evaluated in patients with Group 2 Pulmonary Hypertension (PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF), a serious condition estimated to affect over 600,000 people in the U.S. alone, currently with no approved therapies
   
• Planned initiation of global, 24-week Phase 2 clinical trial to evaluate TX45 administered subcutaneously in subjects with Group 2 PH due to HFpEF (PH-HFpEF) in the third quarter of 2024, with topline trial results expected in 2026
   
• Phase 1a topline trial results of TX45 in healthy volunteers are expected to be released this September, with detailed data to be subsequently presented at a scientific meeting
   
• Phase 1b hemodynamic trial evaluating single doses of TX45 in subjects with Group 2 PH-HFpEF continues to enroll as planned, with topline study results expected in mid-2025
   

WATERTOWN, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ:TECX) (Tectonic), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (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.

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