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Pulmonary arterial hypertension (PAH) is a rare but serious condition characterized by high blood pressure in the arteries that connect the heart to the lungs. This disease leads to the narrowing and thickening of the arterial walls, which impairs blood flow and increases the pressure in the pulmonary arteries. If left untreated, PAH can result in heart failure and other severe complications. Although treatment options for PAH have improved in recent years, only about half of the patients survive the next seven years after diagnosis.
An international research team, with Prof. Dr. Ardeschir Ghofrani (DZL site UGMLC) as leading author, has tested the new drug Seralutinib for pulmonary arterial hypertension. The results of the study are promising. In an international Phase II study, scientists tested the efficacy and safety of Seralutinib across 40 hospitals. Forty-four participants inhaled Seralutinib twice daily for 24 weeks in addition to a standard therapy. Forty-two participants received a placebo. The majority of study participants were women. Various forms of pulmonary hypertension were examined, with idiopathic pulmonary hypertension being the most common.
Seralutinib significantly reduced vascular resistance. A benefit over the placebo group was observed as early as four weeks into the treatment. Particularly in patients with more severe symptoms, the values improved even more markedly, suggesting that Seralutinib may be especially effective in advanced stages of the disease. Seralutinib inhibits an enzyme involved in the remodeling of blood vessels in the lungs, which contributes to pulmonary arterial hypertension. Overall, the drug showed good tolerability. The most common side effect in both groups was cough. Some participants in the Seralutinib group experienced elevated liver enzyme levels. Adverse effects were mostly mild or moderate. Fourteen percent of participants in the Seralutinib group discontinued the study due to side effects, compared to two percent in the placebo group.
A Phase III study for the approval of Seralutinib began in December 2023 and is expected to be completed by October 2025. The study is funded by a pharmaceutical manufacturer.
Frantz, R. P. et al.: Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomized, double-blind, placebo-controlled phase 2 trial. In: The Lancet Respiratory Medicine 2024, doi 10.1016/S2213-2600(24)00072-9.
