Tectonic Therapeutic has reported favourable topline data from the Phase Ia trial of its lead programme TX45 for treating Group 2 pulmonary hypertension-heart failure with preserved ejection fraction (PH-HFpEF).
The single ascending dose trial assessed the safety, tolerability, and pharmacokinetic/pharmacodynamics (PK/PD) of TX45 in healthy subjects, focusing on its ability to increase renal plasma flow.
Go deeper with GlobalData
Doses ranging from 0.3mg/kg to 3mg/kg administered intravenously and 150mg to 600mg given subcutaneously were evaluated in the trial.
The trial results indicated minimal adverse events and no evidence of immune-mediated clearance following treatment with TX45.
A strong PK/PD relationship was established to identify Phase II doses and dosing regimens by assessing the change in renal plasma flow from baseline at various time points after dosing.
In preclinical chronic pulmonary hypertension models, trough exposures associated with maximal activity also showed near-peak renal plasma flow increase on administering TX45.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe PK/PD model derived from the Phase Ia data closely matched the relationship observed in preclinical studies when adjusted for potency differences between species, the company noted.
Based on these models, Tectonic selected dose regimens for the Phase II proof of concept clinical trial in PH-HFpEF patients.
The Phase II trial will randomise patients to 300mg subcutaneously once monthly, 300mg every other week, or placebo.
Following the receipt of the US Food and Drug Administration’s clearance of the investigational new drug application for TX45, subject screening in the Phase II APEX trial has commenced.
The company anticipates reporting topline results from the Phase II trial in 2026.
Tectonic CEO and president Alise Reicin said: “These topline Phase Ia 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.
“Furthermore, the Phase Ia data reveal the successful translation of a robust preclinical model into the clinic. This allowed us to select doses for our global Phase II randomised, six-month clinical trial evaluating the effect of TX45 on PH-HFpEF patients, enriched for those with combined pre- and post-capillary PH.”
