Merck posts full Phase 3 data for pulmonary arterial hypertension (NYSE:MRK)
Merck (NYSE:A) closed ~4% higher on Monday, marking the largest single-day increase since June 2022 after the disclosure of complete Phase 3 results for the biologic sotatercept, which is targeted for the treatment of arterial hypertension pulmonary embolism (PAH) due to vascular disorders.
The The pivotal trial, STELLAR, included 323 adults with PAH who were randomized to receive sotatercept (n=163) or placebo (n=160) in addition to stable background therapy.
In October, Merck (A) indicates that STELLAR met the primary goal of a statistically significant 6-minute walking distance (6MWD) improvement. There were clinically and statistically significant improvements for eight of the nine secondary efficacy outcome measures.
Monday’s full results, as revealed at a medical event and published simultaneously on New England Journal of Medicineindicated that PAH patients receiving sotatercept saw an improvement of 40.8 meters (95% CI, 27.5-54.1; p<0.001) in 6MWD compared to baseline at week 24.
Notably, the candidate had an 84% reduction in the risk of clinical deterioration or death compared with placebo over a mean 32.7 weeks of follow-up.
However, ~91% of patients in the sotatercept arm experienced treatment-emergent adverse events (TEAEs) compared with ~92% in the placebo arm.
In the sotatercept and placebo groups, there was severe TEAE in ~13% and ~18% of patients, while two patients and seven died during treatment. study period, respectively.
Merck (A) stock rallied further Monday after Jefferies initiated it with a Buy recommendation, naming the pharma giant as Its top pharmaceutical selection.