The U.S. Food and Drug Administration (FDA) has provided Tiakis Biotech with advice for a planned Phase 2 clinical trial testing tiprelestat for pulmonary arterial hypertension (PAH). The ATHENA trial, which will assess the treatment’s safety and efficacy, is expected to enroll 90 patients, randomly assigned to receive…
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The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALG-801, Alivegen’s experimental treatment for pulmonary arterial hypertension (PAH). That designation aims to support the development of therapies for rare diseases, or those affecting fewer than 200,000 people in the U.S. It comes with certain…
Cereno Scientific said it has enrolled nine additional people with pulmonary arterial hypertension (PAH) in its expanded access program (EAP) for investigational therapy CS1, bringing the total number of patients in the program to 10. The patients will continue receiving CS1 after completing a Phase 2a clinical trial.
People with pulmonary arterial hypertension (PAH) and their physicians hardly ever agree on the severity of symptoms, a study in the U.S., Europe and Japan reveals. Symptom discordance was more likely when PAH was more severe and was associated with worse health-related quality of life (HRQoL). “Physicians consistently under-recognized the…
Using in-depth analyses and machine learning, scientists have identified several molecules and genes involved in metabolism that may be diagnostic markers of pulmonary arterial hypertension (PAH). Specifically, their research found five small molecules, or metabolites, and three metabolism-related genes that are tied to a PAH diagnosis. All were “identified…
An oxygen-sensing protein called hypoxia-inducible factor-1alpha, or HIF-1alpha, may contribute to worsening pulmonary arterial hypertension (PAH) and is a possible therapeutic target for people with this rare type of pulmonary hypertension, a study by Chinese scientists found. According to the researchers, HIF-1alpha may worsen PAH by increasing the uptake…
Lung tissue and cells from the blood vessels that pass through the lungs derived from people with pulmonary arterial hypertension (PAH) produced fewer vitamin D receptors (VDRs) than normal, a study shows. Treating PAH patient-derived blood vessel cells with calcitriol, the active form of vitamin D, reduced VDR deficiency…
Blood levels of angiopoietin-2, a marker of blood vessel damage, may help predict treatment response and outcomes in pulmonary arterial hypertension (PAH), according to a new study from researchers in the U.S. Levels of D-dimer, a marker of blood clot formation, were also increased in PAH patients, the study…
Elevated blood levels of an inflammatory biomarker called the neutrophil-to-lymphocyte ratio (NLR) were associated with a higher risk of death among people with pulmonary hypertension (PH) related to chronic kidney disease (CKD), according to a recent report. “NLR, which is a convenient and inexpensive parameter, may be a novel…
Indicators of high blood sugar levels, particularly stress hyperglycemia ratio (SHR), may predict clinical worsening in people with idiopathic pulmonary arterial hypertension, a study in China indicates. Clinical worsening was defined as the first occurrence of lung transplant, being rehospitalized due to heart failure, or death from any cause.
LungFit PH, Beyond Air’s device for administering nitric oxide therapy, has received European CE mark approval for persistent pulmonary hypertension in newborns (PPHN). This approval allows the company to market the device in the European Union and all other countries that recognize this certification, and also extends its…
Winrevair (sotatercept-csrk) significantly reduced the risk of all-cause death, a lung transplant, or hospitalization among adults with pulmonary arterial hypertension (PAH) at a high risk of dying enrolled in a Phase 3 clinical trial. These top-line findings in the ongoing ZENITH trial (NCT04896008), testing the Merck…
