HQ Team
March 7, 2023: Merck announced its experimental trial on patients with pulmonary arterial hypertension had led to an extension in walking distance and reduced exacerbating the condition by 84%.
Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance of 40.8 meters from baseline at week 24, the study’s primary endpoint,” according to a Merck statement.
In addition, the sotatercept demonstrated “statistically significant and clinically meaningful improvements” in eight of nine secondary outcome measures, including improvements in WHO functional class and pulmonary vascular resistance.
“Sotatercept reduced the risk of clinical worsening or death by 84% compared to placebo with a median follow-up of 32.7 weeks,” according to the statement.
On November 22, Merck acquired Acceleron Pharma, a publicly traded biopharmaceutical company, for a total equity value of $11.5 billion. Merck acquired exclusive rights to sotatercept in the pulmonary hypertension field through the acquisition. Sotatercept is the subject of a licensing agreement with Bristol Myers Squibb.
Short-term, long-term
The protein has potential to improve short-term and long-term clinical outcomes in patients with pulmonary arterial hypertension, a progressive and life-threatening blood vessel disorder.
The disorder constricts small pulmonary arteries and elevates blood pressure in pulmonary circulation.
About 40,000 people in the US are living with the disorder. The disease progresses rapidly for many patients and significantly strains the heart, leading to limited physical activity, heart failure and reduced life expectancy.
The 5-year mortality rate for patients with the disease is about 43%.
The data were presented today at the American College of Cardiology’s 72nd Annual Scientific Session with the World Heart Federation’s World Congress of Cardiology and simultaneously published in The New England Journal of Medicine.
Life-threatening
“PAH is a rare, rapidly progressive, debilitating and ultimately life-threatening condition with a five-year mortality rate of 43%,” said Dr Marius Hoeper, Hannover Medical School, Germany, and lead investigator.
“Sotatercept demonstrated profound improvements across the primary endpoint of a six-minute walk distance and multiple secondary endpoints, including advances in WHO functional class and pulmonary vascular resistance.
“These…results show the potential of sotatercept and the approach of targeting cellular signalling associated with vascular hyperproliferation and pathological remodelling for the treatment for PAH.”
The results are significant to physicians and patients and highlight the critical role sotatercept may play in improving exercise capacity and other meaningful clinical outcome measures for patients with PAH,” said Dr. Dean Y. Li, president of Merck Research Laboratories.
“These findings are compelling given the profound reduction in the risk of clinical worsening or death in patients treated with sotatercept on top of background therapy. We look forward to discussing these pivotal data with health authorities and are urgently working to bring this potential new treatment option to patients,” Li said.
Once every three weeks
The study enrolled a total of 323 participants who were randomized to receive either sotatercept once every three weeks at a dose of 0.3 mg/kg at visit one and a dose of 0.7 mg/kg after that or placebo added to stable background pulmonary arterial therapy.
Treatment-emergent adverse events occurred in 90.8% of patients who received sotatercept compared to 91.9% of patients who received placebo.
Severe adverse events were observed in 12.9% versus 18.1% of patients. Adverse events that occurred more frequently with sotatercept versus placebo were bleeding events, telangiectasia, increased haemoglobin levels, thrombocytopenia, blood pressure, and dizziness.
