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Tectonic Therapeutic Announces US IND Clearance for Lead Program, TX45
TX45 is an Fc-relaxin fusion protein being evaluated in patients with Group 2 Pulmonary Hypertension (PH) due to Heart Failure with Preserved Ejection
About this update from Tectonic Therapeutic, Inc.
[{"type":"text","content":"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 therapiesPlanned 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 2026Phase 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 meetingPhase 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. “We believe our novel Fc-relaxin fusion protein has been engineered to optimize the pharmacology of TX45,” commented Alise Reicin, M.D., President and CEO of Tectonic. “The safety, pharmacokinetic and pharmacodynamic data we have received to date supports the initiation of our Phase 2 clinical trial in our target patient population. We expect to report topline results from our Phase 1a single dose healthy volunteer trial this September and topline results from our Phase 1b single dose patient trial in mid-2025. We remain enthusiastic about the potential of TX45 to address the unmet needs of patients living with PH-HFpEF for whom there i...