A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

Launched by TECTONIC THERAPEUTIC · Sep 25, 2024

Keywords

ClinConnect Summary

The APEX Study is a clinical trial investigating a new medication called TX000045 for patients who have pulmonary hypertension (high blood pressure in the lungs) caused by heart failure, particularly in those whose heart pumps normally but doesn't work effectively. This study will last for 24 weeks and involves two different doses of TX000045, compared to a placebo (a harmless pill with no active medication). The trial is currently recruiting participants aged 18 to 80 who meet specific health criteria, such as having a diagnosis of pulmonary hypertension due to heart failure and being able to walk a certain distance in a six-minute test.

Participants in this study can expect to receive either the study medication or a placebo, and neither they nor the researchers will know which one they are getting, ensuring an unbiased evaluation of the treatment's effects. To join the study, individuals must be in stable health with certain heart conditions but should not have other serious illnesses or recent hospitalizations. It’s a great opportunity for eligible patients to contribute to research that could help improve treatments for pulmonary hypertension related to heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
• • 2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
• • 3. Has NYHA functional class II- III heart failure.
• • 4. Has 6MWT distance from 100 to 450m.
• • 5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
• • 6. Is able to understand and provide documented consent for participation.
• Exclusion Criteria:
• • 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
• • 2. Current or recent hospitalization prior to screening.
• • 3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
• • 4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
• • 5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
• • 6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.
• • 7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
• 8. Has any of the following clinical laboratory values during screening:
• • 1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN;
• • 2. eGFR \<30 mL/min/1.73 m2;
• • 3. HbA1c (glycosylated hemoglobin) \>9%;
• • 4. Platelet count \<50,000/millimeter cube;
• • 5. Hemoglobin \<10.0g/dL;
• • 9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
• • 10. Is pregnant or breastfeeding.
• • 11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
• • 12. Has a history of drug or alcohol abuse.
• • 13. Was recently dosed in any clinical research study.