Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 9, 2020

Merck’s gefapixant decreases chronic cough frequency in Phase III trials

Merck (MSD) has reported positive results from the pivotal Phase III COUGH-1 and COUGH-2 clinical trials of gefapixant (MK-7264) to treat refractory or unexplained chronic cough. 

Merck (MSD) has reported positive results from the pivotal Phase III COUGH-1 and COUGH-2 clinical trials of gefapixant (MK-7264) to treat refractory or unexplained chronic cough.

Gefapixant is an experimental, oral, selective antagonist of the P2X3 receptor, which is present on sensory nerve fibers, mainly C fibers, in the airway lining.

The companion COUGH-1 and COUGH-2 studies assessed the safety and efficacy of the drug.

Data showed that adults on gefapixant 45mg twice-daily had a statistically significant reduction in 24-hour cough frequency compared to placebo at 12 weeks in COUGH-1 and 24 weeks in COUGH-2.

In addition, Merck said that the 15mg twice-daily dose of the drug missed the primary efficacy endpoint in both trials.

Merck Research Laboratories chief medical officer and global clinical development senior vice-president and head Dr Roy Baynes said: “COUGH-1 and COUGH-2 are the first companion Phase III trials in refractory or unexplained chronic cough, underscoring Merck’s commitment to fully researching the potential for gefapixant in this patient population.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

“Both trials met the primary endpoint at the 45mg twice-daily dosage, significantly reducing cough frequency in these patients, and we are grateful for the opportunity to share these data with the scientific community.”

The international, randomised, double-blind, placebo-controlled COUGH-1 and COUGH-2 studies involved a total of 2,044 participants.

Apart from the primary efficacy outcome measure of 24-hour cough frequency, the trial evaluated secondary endpoints, such as awake coughs per hour and a greater than 1.3-point rise in the Leicester Cough Questionnaire (LCQ) total score.

Awake cough frequency results were found to be generally similar to the 24-hour cough frequency outcome, demonstrating statistical significance with the 45mg twice-daily dose COUGH-2 and trending towards significance in COUGH-1.

In the 45mg group, 77.1% of participants achieved a clinically relevent improvement in their quality of life related to cough, as determined using the LCQ.

Furthermore, the safety and tolerability profile of gefapixant was observed to be consistent with previous study data.

In June this year, Merck reported positive results from two Phase III trials of its investigational 15-valent pneumococcal conjugate vaccine, V114.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy