Tectonic Therapeutics Announces Positive Phase 1a Results For TX45 In Treating Group 2 PH-HFpEF

(RTTNews) - Tectonic Therapeutics Inc. (TECX) announced favorable Phase 1a topline data for its lead asset, TX45, a long-acting, potentially best-in-class relaxin developed for the treatment of Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF),

The Phase 1a clinical trial is a single ascending dose study in healthy volunteers designed to assess the safety and tolerability of TX45 in addition to the pharmacokinetic (PK) and pharmacodynamic (PD) profile of TX45 based upon relaxin's known ability to increase renal plasma flow. TX45 doses of 0.3, 1 and 3 mg/kg administered intravenously (IV) and 150, 300 and 600 mg given subcutaneously (SC) were examined. The trial demonstrated that TX45 had minimal adverse events and no evidence of immune-mediated clearance.

The company noted that the topline Phase 1a findings for TX45 validated the preliminary data previously presented at lower doses. Furthermore, the Phase 1a data reveal the successful translation of a robust preclinical model into the clinic. This allowed the company to select doses for its global Phase 2 randomized, 6-month clinical trial evaluating the effect of TX45 on PH-HFpEF patients, enriched for those with combined pre- and post-capillary PH.

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