The study will evaluate the safety and hemodynamic effects of single-dose TX45 in patients with Group 2 Pulmonary Hypertension secondary to Heart Failure with preserved Ejection Fraction (Group 2 PH with HFpEF).
Group 2 PH with HFpEF impacts over 600,000 patients in the US and is associated with significant morbidity and mortality. Importantly, there are no approved therapies for this condition. 'Our goal is to leverage relaxin's vasodilatory, anti-fibrotic and anti-inflammatory properties to provide improved treatment outcomes for patients with Group 2 PH,' said
Demonstrating a durable treatment effect with the native relaxin protein can be challenging due to its intrinsic short half-life; however, initial data from Tectonic's ongoing Phase 1A study suggests that TX45 has the potential to overcome previous challenges and to be a best-in-class therapy. Topline results from the Phase 1A study are expected to be reported in mid-2024, followed by results from the Phase 1B study in Group 2 PH with HFpEF patients in 2025. A randomized Phase 2 study is planned to begin in H2 2024.
Phase 1B study overview
The Phase 1B study with TX45 in patients with Group 2 PH with HFpEF is a single dose, open-label study to evaluate safety, tolerability and acute hemodynamic effects of intravenous administration of TX45. The study will evaluate the effect of TX45 on hemodynamic parameters, as determined by right heart catheterization and echocardiography.
About TX45, a long-acting Fc-relaxin fusion protein
Known as a 'pregnancy hormone,' relaxin is upregulated during pregnancy to help the expectant mother's cardiovascular system meet the increased demand from the developing fetus, and to remodel tissues and musculoskeletal structures involved in childbirth. Because of these features, it offers a similarly broad range of potential therapeutic applications with significant benefits expected in cardio-pulmonary diseases.
Tectonic's TX45 Fc-relaxin fusion protein is a potential best-in-class agent, resulting from protein engineering efforts to overcome limitations associated with the natural human hormone and achieve both optimal in vitro (biophysical and developability), as well as in vivo (pharmacokinetic and pharmacodynamic, or 'PK/PD') properties. Tectonic is leveraging relaxin's vasodilatory and anti-fibrotic properties with the goal of improving treatment outcomes for patients with Group 2 PH.
About Pulmonary Hypertension and HFpEF
The
About Tectonic Therapeutic
Tectonic Therapeutic, co-founded by
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