TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
Has NYHA functional class II- III heart failure.
Has 6MWT distance from 100 to 450m.
Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
Current or recent hospitalization prior to screening.
Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
Tectonic Therapeutic
Lead sponsor