Merck Halts HYPERION Trial of Winrevair Early Due to Overwhelming Efficacy in PAH Treatment

Merck announced the early termination of the Phase 3 HYPERION trial evaluating Winrevair (sotatercept-csrk) in recently diagnosed adults with pulmonary arterial hypertension (PAH)12.

The decision to stop the trial early was based on positive results from the interim analysis of the ZENITH trial and the overall robust efficacy data from the Winrevair clinical program12.

The external steering committee and Merck concluded that continuing the placebo-controlled trial would be unethical due to the loss of clinical equipoise14.

Winrevair is currently approved in the United States and 38 other countries for treating PAH and reducing the risk of clinical worsening events3.

All HYPERION study participants will now have the opportunity to access Winrevair through the Phase 3 SOTERIA open-label extension study12.

The complete findings from the HYPERION study are expected to be presented at a future medical congress later this year24.

PAH is a rare, progressive, and life-threatening disease affecting approximately 40,000 people in the United States, with a five-year mortality rate of about 43%3.

Sources:

1. https://www.merck.com/news/merck-announces-decision-to-stop-phase-3-hyperion-trial-evaluating-winrevair-sotatercept-csrk-early-and-move-to-final-analysis/

2. https://www.stocktitan.net/news/MRK/merck-announces-decision-to-stop-phase-3-hyperion-trial-evaluating-vrbbolbq7c88.html

3. https://www.managedhealthcareexecutive.com/view/another-trial-of-winrevair-stopped-early-due-to-positive-efficacy

4. https://www.hcplive.com/view/merck-halts-phase-3-hyperion-trial-of-sotatercept-for-final-analysis