Merck's Winrevair Shows Promise in Underserved Pulmonary Hypertension Indication

Merck's activin blocker Winrevair continues to demonstrate its potential as a leading treatment for pulmonary hypertension, with new mid-stage data showing significant benefits for patients with combined post- and precapillary pulmonary hypertension (CpcPH).

Phase II CADENCE Study Yields Positive Results

Merck announced that Winrevair met its primary endpoint in the Phase II CADENCE study, demonstrating a statistically significant and clinically meaningful decrease in pulmonary vascular resistance at 24 weeks compared to placebo. The study focused on patients with CpcPH due to heart failure with preserved ejection fraction (HFpEF), an indication with limited treatment options.

While specific data were not disclosed, Merck reported that Winrevair's safety profile in the CADENCE study was generally consistent with previous findings. The company plans to present detailed results at an upcoming medical meeting.

Winrevair's Growing Success in Pulmonary Hypertension

The positive CADENCE results add to Winrevair's impressive track record in treating various forms of pulmonary hypertension:

• In March 2024, Winrevair received FDA approval for pulmonary arterial hypertension, hailed as a "game changer" for the condition.
• The Phase III ZENITH study, reported in April, showed a 76% decrease in the likelihood of major morbidity or mortality compared to placebo.
• September saw the release of detailed data from the Phase III HYPERION study, demonstrating a similar 76% reduction in clinical worsening events.

Future Prospects and Market Potential

With these encouraging results, Merck plans to advance Winrevair into late-stage development for CpcPH due to HFpEF. BMO Capital Markets analysts note that this indication represents a significant commercial opportunity for Merck, given the few available treatment options.

Winrevair's potential to address the underlying biology of CpcPH, rather than simply managing heart failure symptoms, could set it apart from existing therapies. As the pharmaceutical industry eagerly awaits full CADENCE data, particularly regarding functional outcomes such as the 6-minute walk test, Winrevair continues to solidify its position as a promising treatment for various forms of pulmonary hypertension.