MSD presents Phase 3 data for its Investigational Activin Signaling Inhibitor, in Adults with Pulmonary Arterial Hypertension on Background Therapy

pharmafile | March 9, 2023 | News story | Business Services  

LONDON, UK, March 6, 2023 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK)) today announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, MSD’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept demonstrated statistically significant improvement in exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint.1

In addition, sotatercept demonstrated statistically significant and clinically meaningful improvements in eight of nine secondary endpoints, including reducing the risk of death or clinical worsening by 84% compared to placebo with a median follow-up of 32.7 weeks (HR=0.16 [95% CI, 0.08-0.35]; p<0.001), and improvements in WHO functional class (WHO FC) and pulmonary vascular resistance (PVR). 1 The safety profile of sotatercept was generally consistent with that observed in previous studies with sotatercept. Treatment-emergent adverse events (TEAEs) occurred in 90.8% of patients who received sotatercept versus 91.9% of patients who received placebo, while severe TEAEs were observed in 12.9% versus 18.1% of patients, respectively. Adverse events that occurred more frequently with sotatercept versus placebo were bleeding events, telangiectasia, increased hemoglobin levels, thrombocytopenia, increased blood pressure, and dizziness. 1

These data were presented today at the American College of Cardiology’s 72nd Annual Scientific Session Together with World Heart Federation’s World Congress of Cardiology and simultaneously published in The New England Journal of Medicine.

Dr Dilruwan Herath, Medical Director, MSD UK & Ireland, said:

“PAH is a life threatening condition, that negatively impacts an individual’s quality of life and health significantly over time. Treatment options are limited and long term survival worse than some cancers. Despite this there is little awareness of the needs of these patients amongst the public.

“With the primary and several of the secondary endpoints being statistically and clinically significant we look forward to working with the UK’s medicines regulator to assess the efficacy and safety data fully, hopefully bringing us one step closer to providing benefit for PAH patients outside of clinical studies and changing the PAH treatment paradigm in the UK.”

Dr Iain Armstrong, Chair of the national charity Pulmonary Hypertension Association UK (PHA UK) said:

“As a patient organisation we welcome new developments in this rare disease area, and we are encouraged by the results of this trial. As well as the impact on life expectancy, pulmonary hypertension carries a high burden of symptoms – so therapies that improve quality of life as well as survival rates are vital. There have been huge advances in the treatment of this disease over the last 20 years, and we hope that sotatercept will become another tool in the arsenal, ultimately making a difference to those living with pulmonary hypertension.”

Dr Colin Church, Respiratory Consultant, The Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital and STELLAR investigator, said:

“This is an exciting time to be involved as a physician caring for patients with pulmonary arterial hypertension (PAH). The data released from the STELLAR trial has given us the hope that we now have a treatment for pulmonary arterial hypertension which can impact on a key signalling vascular pathway and may actually target the underlying disease process.

“This clinical trial showed that in patients taking the drug, sotatercept, there was an improvement in exercise capacity as measured by the traditional 6 minute walk test. However and perhaps more excitingly there was also a fall in the pulmonary artery pressure and fewer patients in the treatment group showed signs of clinical deterioration.

“The trial also demonstrated that the drug had an effect even when patients were already on maximal established PAH vasodilator therapy which is great news for patients and offers them a new form of treatment in this area.

“This data and the fact there are a large number of other ongoing clinical trials for patients with PAH, shows us the benefits of advancing clinical research in this area with the aim to eventually curing pulmonary arterial hypertension.”

Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening disorder where the blood vessels that supply the lungs become narrowed or thickened, causing increased pressure in the blood travelling through the lungs. In people with PAH the blood vessels in the lungs cannot pick up as much oxygen as they should, so the body does not get as much oxygen as it needs.2

Approximately 4,200 people are currently living with PAH in the UK, with around 600 new patients diagnosed in the UK each year. 3

People with PAH can appear well at rest, but through simple activity such as climbing stairs they may experience symptoms including breathlessness, chest pain and fatigue. The disease progresses rapidly for many patients. 2

PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. Currently in the UK, only 57% of patients with PAH are alive at five years after being diagnosed. 3 

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