MSD has revealed new topline efficacy results from two ongoing pivotal Phase III trials, evaluating gefapixant (MK-7264) in refractory or unexplained chronic cough.
The the studies, a 45mg twice daily dose of the investigational, orally administered, selective P2X3 receptor antagonist met its primary efficacy endpoints. The company confirmed that the dosing demonstrated a statistically significant decrease in 24-hour coughs per hour, compared to placebo at 12 and 24 weeks, in COUGH-1 and COUGH-2, respectively.
On the other hand, the gefapixant 15mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase III study.
“The burden for patients faced with this disease underscores the need for effective therapeutic options for refractory and unexplained chronic cough,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories. “We are pleased gefapixant at the 45 mg dose met the primary efficacy endpoints in both Phase 3 studies and we look forward to sharing the detailed findings at an upcoming medical meeting.”
The prevalence of chronic cough - defined as a cough lasting more than eight weeks - is estimated at 10% of the general adult population globally, and in up to 46% of these cases, no treatable cause can be identified despite a thorough diagnostic investigation. As it stands, there are no approved therapies for the treatment of chronic cough.
