MSD, known as Merck & Co. in the United States and Canada, announces today at the International Congress of the European Society of Pulmonology – Ers 2023 new analyzes from studies on sotatercept, a new biological inhibitor of the activin signal, for adults suffering from hypertension pulmonary artery – Pah (WHO Group 1). A new exploratory post-hoc analysis of data relating to right heart catheterization and echocardiography of patients in the phase 3 Stellar study – reports a note – showed that patients treated with sotatercept for 24 weeks, in addition to basis, significantly reduced the size of the right heart and improved right ventricular function and hemodynamic status. This analysis was the subject of an oral presentation at the Ers meeting underway in Milan, with simultaneous publication in the ‘European Respiratory Journal’. We also presented a preliminary analysis of the Soteria phase 3 open-label extension study, which represents the longest analysis of the safety and efficacy of sotatercept available to date.
“There is an urgent need for new approaches to manage Pah, a rare, progressive and high-mortality disease – said Eliav Barr, Senior Vice President and head of global clinical development, medical director of Merck Research Laboratories – The latter data are based on the clinically significant efficacy results from the Stellar study and support our belief that sotatercept has the potential to transform the treatment of Pah. Pah can place strain on the heart and lead to eventual right heart failure. We are therefore particularly confident in Stellar’s exploratory analysis, which shows that treatment with sotatercept reduced the size of the right heart and improved function.”
Preliminary efficacy results from the Stellar study, in which sotatercept added to background therapy demonstrated a statistically significant and clinically relevant improvement at 24 weeks in 6-minute walk distance, and in 8 of 9 secondary endpoints, were presented to Acc.2023/Wcc and published in ‘The New England Journal of Medicine’. MSD has applied for regulatory approval of sotatercept with the US FDA, and plans to submit applications to other regulatory agencies around the world.
“The new data presented at the Ers congress show great clinical efficacy of sotatercept in patients with pulmonary arterial hypertension. This molecule – explains Stefano Ghio, acting director of the Cardiology 1 unit of the Irccs Policlinico San Matteo Pavia Foundation – is the first and only inhibitor of activin signaling that has the potential to rebalance the dysregulated cell proliferation that is believed to be the primum movens of pulmonary vascular disease. The new data show that treatment with sotatercept significantly improves the function of the right heart, the ability of pumping blood into the diseased pulmonary vessels is the main determinant of the survival of these patients. Furthermore, the clinical improvement after sotatercept lasts over time and is associated with a reduction in other therapies taken by patients, confirming the fact that sotatercept therapy is capable of acting on the true pathogenetic mechanisms underlying pulmonary arterial hypertension”.
“Inventing for life has always been our mission – declares Nicoletta Luppi, president and managing director of MSD Italia – and it is also so in the area of pulmonary arterial hypertension where, thanks to our constant commitment to research to generate value, we want making innovative solutions available to people in urgent need. Results such as those presented at the Ers congress give us great confidence in seeing how our innovation can represent a real turning point for the benefit of the scientific community and patients living with a pathology as rare and disabling as pulmonary arterial hypertension. Science and our research today allow us to return with innovation in the cardiovascular field and demonstrate our great commitment in the field of rare diseases, where the need and urgency of new therapies is even stronger, considering the diagnostic and healthcare problems connected to them. As a company, we will engage in discussions with the institutions and the scientific community so that our therapeutic innovation reaches people who suffer from pulmonary arterial hypertension promptly and effectively. this translates not only into more life, but also into a better life.”
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