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Tectonic Therapeutic Announces Favorable Phase 1a Safety, Tolerability and PK/PD Results for Lead Program TX45
TX45 was well-tolerated with no observed immunogenicity, and demonstrated a favorable PK/PD relationship which was used to identify doses for the Phase 2
About this update from Tectonic Therapeutic, Inc.
[{"type":"text","content":"TX45 was well-tolerated with no observed immunogenicity, and demonstrated a favorable PK/PD relationship which was used to identify doses for the Phase 2 clinical trial Results to be presented at the American Heart Association (AHA) Scientific Sessions in November 2024 Phase 1b single dose hemodynamic proof-of-concept clinical trial in Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) escalated to the highest dose of TX45 (3 mg/kg) based on favorable tolerability profile observed at lower doses, with topline trial results expected in the second quarter of 2025 WATERTOWN, Mass., Sept. 19, 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 favorable Phase 1a topline data for its lead asset TX45, a long-acting, potentially best-in-class relaxin. TX45 is being developed for the treatment of Group 2 PH-HFpEF. “These topline Phase 1a findings for TX45 validate the preliminary data previously presented at lower doses, and we look forward to sharing the full trial results at the AHA Scientific Sessions later this year,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Furthermore, the Phase 1a data reveal the successful translation of a robust preclinical model into the clinic. This allowed us to select doses for our 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.” 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. By assessing the change in renal plasma flow from baseline at several timepoints after dosing, a robust PK/PD relationship was established to identify the P...