Positive results from a proof-of-concept study evaluating Merck’s Winrevair pave the way for further study of the activin signaling inhibitor as a potential treatment for a subset of heart failure patients.
The phase 2 Cadence trial met its primary endpoint, showing that Winrevair improved the ability of blood to transition through the lungs to the heart in patients with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF).
Without revealing data, Merck said that Winrevair provided a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) after 24 weeks compared to placebo.
PVR is “an important hemodynamic measurement related to cardiac and pulmonary blood vessel function that has the potential to translate into improved outcomes” for those in the patient group, Mahesh Patel, Merck’s global clinical development chief, said in a release.
Merck will present data from the trial at a future medical conference and will advance Winrevair to a phase 3 study in the indication.
CpcPH is a subset of pulmonary hypertension due to left heart disease (PH-LHD), also known as Group 2 pulmonary hypertension, Merck explained. Those with CpcPH generally have poorer outcomes than others in the disease class. There are no treatments specifically approved for CpcPH, Merck added.
The trial results build on the momentum for Winrevair, which was approved in March of last year for pulmonary arterial hypertension (PAH). Three weeks ago, the FDA updated Winrevair’s label, detailing its ability to reduce the risk of hospitalization, lung transplantation and death.
Merck gained Winrevair as a part of its $11.5 billion buyout of Acceleron in 2021. The first-in-class treatment generated $360 million in sales in the third quarter and has accounted for $976 million in revenue this year. Citi has projected 2030 sales of the treatment to reach $6.2 billion.
“With a significant unmet need and a large opportunity in PH-LHD, the Cadence data today unlocks a new population for Winrevair,” Citi analyst Geoffrey Meacham, Ph.D., wrote in a note to clients. “We continue to be encouraged by the long-term opportunity for Winrevair and highlight upside potential with further label expansion.”