Positive results from a pair of clinical trials

Two companies have announced good results from clinical trials in the past few weeks.

Merck’s Phase 2 proof-of-concept CADENCE trial of two different doses of sotatercept for some Group 2 pulmonary hypertension patients succeeded. Trial participants had combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Participants who received sotatercept showed significant improvements in their pulmonary vascular resistance, which was the study’s primary focus, compared to participants who received a placebo. They also had apparent improvements in several other measures such as mean pulmonary arterial pressure, pulmonary arterial wedge pressure, and NT-proBNP levels, but because of the study design these were not formally tested for statistical significance. Based on these results, Merck is now planning a Phase 3 trial for sotatercept in CpcPH-HFpEF patients.

United Therapeutics also had a successful result with its Phase 3 TETON-1 study of inhaled treprostinil in people with pulmonary fibrosis, which could be good news for some Group 3 pulmonary hypertension patients. In Canada, treprostinil is only available intravenously or subcutaneously, but inhaled versions have been available in the United States for several years. United Therapeutics will use these study results to attempt to add idiopathic pulmonary fibrosis to the list of conditions for which inhaled treprostinil is approved.

Taken together, these early successes point to a promising and expanding treatment landscape for people with Groups 2 and 3 pulmonary hypertension. As always, however, further research will be essential.