Merck has presented the two Phase 3 trials (COUGH-1 and COUGH-2) of gefapixant at the European Respiratory Society International Congress 2020.
The drug is an investigation P2X3 receptor antagonist, indicated for treating refractory or unexplained chronic cough. The drug is in trials for refractory cough, a type of cough which persists even after treating the underlying conditions, and unexplained cough, a type of cough which is not diagnosed despite thorough evaluation.
COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are Phase 3, randomized, double-blind, placebo-controlled studies. The study was intended to evaluate the safety and efficacy of gefaxiant. The drug is intended for reducing cough frequency in adult patients with refractory or unexplained chronic cough. A total of 2,044 patients were included in both the trials; 24-hour cough frequency at week 12 and 24-hour cough frequency at week 24 were considered as the primary endpoint. An ambulatory digital audio recording device is used to record cough.
Geometric mean 24-hour cough frequency at week 12:
Placebo: 10.33
Gefapixant 15 mg: 9.66
Gefapixant 45 mg: 7.05
Geometric mean 24-hour cough frequency at week 24:
Placebo: 8.34
Gefapixant 15 mg: 8.10
Gefapixant 45 mg: 6.83
About chronic cough:
About 5-10% of adult patients globally are estimated to be suffering from a chronic cough. There are no therapeutic options available for treating refractory chronic cough or unexplained chronic cough.
For pipeline, market overview, and market access reports (syndicate and customized) please write to sales@firstviewinsight.com
For all syndicate reports: Click here