Pulmonary Hypertension associated with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) is classified as Group 2 pulmonary hypertension by the World Health Organization (WHO). It is a type of heart failure in which the heart still pumps normally but becomes too stiff to fill properly with blood between heartbeats. This can cause pressure to build up in the heart and lungs, leading to pulmonary hypertension.
Tectonic Therapeutic’s Phase 2 APEX study includes 191 participants from 14 countries. Researchers expect the first results in early 2027. TX45 is designed to help reduce pressure in the blood vessels of the lungs, making it easier for the heart to pump blood. It contains a long-lasting form of relaxin, a natural hormone that helps widen blood vessels and may improve heart function. Earlier studies showed encouraging results after a single dose.
In this study participants receive TX45 or a placebo for 24 weeks. Researchers will assess:
- Whether TX45 safely reduces pressure and resistance in the lung blood vessels.
- Whether it improves heart function, exercise capacity, and other signs of disease.
Most participants in the study have a more severe form of PH-HFpEF called combined pre- and post-capillary pulmonary hypertension (CpcPH), which affects both the blood vessels in the lungs and the left side of the heart.
What does this mean for patients?
There are currently no approved treatments specifically for PH-HFpEF, so new treatment options are urgently needed. This study will help researchers understand whether TX45 can safely improve heart and lung function in people with this condition. Although the study is now fully enrolled, TX45 is still an experimental treatment, and we will need to wait for the first results in early 2027 to find out whether it is safe and effective.
Read more at this link on Pulmonary Hypertension News
See also the company press release here