The primary endpoint of the study and a recognized proxy for functional improvement and decreased symptom burden was the six-minute walking test, which measured improvements in walking distance in patients with pulmonary arterial hypertension (PAH), a severe, progressive condition that affects the heart and lungs. Patients receiving sotatercept, a novel first-in-class medication, in addition to current therapy experienced significant improvements in walking distance. In comparison to patients receiving normal medication, those who received sotatercept also had an 84% lower probability of passing away or having their condition worsen. The work is being presented at the World Congress of Cardiology and the American College of Cardiology’s Annual Scientific Session.
The right side of the heart’s blood flow is blocked by the narrowing and scarring of the small blood vessels in the lungs, which raises blood pressure in the lungs and requires the heart to work harder to pump blood through the narrowed arteries. This condition, known as PAH, is rare and progressive. Small pulmonary arteries’ underlying structural alterations are brought on by an imbalance between growth-inhibiting and -promoting mediators, such as activins. About 1 in 5 individuals with PAH have a family history of the condition, which is frequently seen in female patients between the ages of 30 and 60. The symptoms of PAH, such as shortness of breath, exhaustion, swelling in the legs and feet, vertigo or fainting spells, chest pain, and heart palpitations, can lead the diagnosis to be delayed.
More than 10 drugs have received approval to treat PAH globally. Nonetheless, despite receiving treatment with as many as three drugs, many patients still experience severe symptoms. According to Hoeper, the disease can advance quickly, and the median survival following diagnosis with available treatments is only about seven years. This highlights the need for the development of innovative therapeutics. An incomplete reversal of the disease process may occur as a result of sotatercept, a first-in-class activin signaling inhibitor, which functions by obstructing aberrant signaling between cells in the pulmonary blood arteries.
In 20 countries, the Phase 3 STELLAR trial enrolled 323 PAH patients (median age 48 years; 79% women). 60% of the patients had significant symptoms at enrollment after receiving three drugs’ worth of maximum therapy. Several individuals experienced acute shortness of breath.The trial’s primary endpoint was the change in the distance patients could walk in six minutes (known as the six-minute walk distance or 6MWD) at 24 weeks. The average improvement in 6MWD among patients receiving sotatercept was 40.8 meters (134.5 feet, about a half of a typical city block), while patients who received the placebo showed no improvement. The change was statistically significant and exceeded the minimum of 33 meters (about 108 feet) that, according to earlier research, patients experienced as a noticeable improvement in their walking capacity, Hoeper said.
