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Merck: Gefapixant Significantly Reduced Cough Frequency Compared To Placebo In Two Phase 3 Trials

Merck & Co. Inc. (MRK) on Tuesday announced the results from two pivotal Phase 3 trials, COUGH-1 and COUGH-2, evaluating the efficacy and safety of gefapixant (MK-7264) for the potential treatment of refractory or unexplained chronic cough.

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist.

The primary efficacy outcomes measure for COUGH-1 and COUGH-2 were 24-hour cough frequency at week 12, and 24-hour cough frequency at week 24, respectively, measured using an ambulatory digital audio recording device.

In the two studies, adult patients treated with gefapixant 45 mg twice daily demonstrated a statistically significant reduction in 24-hour cough frequency compared to placebo at 12 weeks (COUGH-1) and 24 weeks (COUGH-2). The reduction in 24-hour cough frequency was 18.45 percent relative to placebo in COUGH-1, while a 14.64 percent reduction was recorded in COUGH-2.

"Both trials met the primary endpoint at the 45 mg 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," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

However, Merck noted that the gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study.

COUGH-1 and COUGH-2 are the first companion Phase 3 trials ever conducted in patients with refractory chronic cough, a cough that persists despite appropriate treatment of underlying conditions, or unexplained chronic cough, a cough where the underlying cause cannot be identified despite a thorough evaluation.

Merck said it presented data from the Phase 3 COUGH-1 and COUGH-2 trials at the Virtual European Respiratory Society or ERS International Congress 2020.

The company plans to share data from COUGH-1 and COUGH-2 with regulatory authorities worldwide.

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