With its aging products, and somewhat overtaken by its competitors, the star of the American pharmaceutical giant MSD had, in the cardiovascular field, faded in recent years. For the past few days, it has been shining again thanks to the good phase 3 results of Sotatercept, its drug candidate for treating pulmonary arterial hypertension.
Little known, this rare disease, which affects around 30,000 people in Europe – very often women between the ages of 30 and 60 – has no treatment to date that can cure it. It is characterized by the gradual narrowing of the small pulmonary arteries, which forces the heart to work harder to pump blood. Exhausted, the patients can no longer take a few steps without being out of breath. In 43% of cases, patients die within five years.
The results of the Stellar clinical trial to evaluate Sotatercept, unveiled on Monday March 6 at the annual meeting of the American College of Cardiology, the global high mass of innovation in cardiovascular disease, however, suggest a new hope. “This is our first clinical trial on this drug. No one had anticipated such positive results from the start.”underlines Professor Dean Li, president of research and development of the pharmaceutical group.
“Reshaping the Pulmonary Artery”
The primary endpoint of the trial was how far patients could walk in six minutes. With 40.8 meters on the clock, MSD’s biotherapy exceeded the minimum threshold of 33 meters, considered significant. Above all, it showed an 84% reduction in the risk of death or worsening of the disease in patients who received the treatment compared to the placebo.
« These impressive results show that we have the opportunity to make a difference for patients. We are conducting other clinical trials, still open to recruitment, on larger patient populations to better understand them », observe M. Li.
Current treatments consist of dilating the blood vessels. Using a different mechanism, this drug “ helps reshape the pulmonary artery “explains Mr. Li, thus directly attacking the cause of the disease rather than its symptoms. The laboratory hopes to obtain approval from health authorities in the United States and Europe in 2024 to be able to market it. He is already considering extending his research to test it on other diseases, in particular to treat diastolic heart failure.
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