Merck Announces Presentation of Phase 2 Results for MK-7264, an Investigational, P2X3 Receptor Antagonist, Being Evaluated for the Treatment of Chronic Cough


May 22, 2017 10:20 am ET

Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced the presentation of results from a Phase 2 study
evaluating the safety, efficacy and therapeutic dose range of MK-7264
(formerly AF-219) for the treatment of chronic cough. The highest dose
evaluated, 50 mg, reduced Awake Cough Frequency (coughs/hour), the
primary endpoint, by 37 percent from baseline relative to placebo
(p=0.003). The 50 mg dose also demonstrated a reduction in
patient-reported cough severity. Lower doses (7.5 mg and 20 mg) were not
statistically significant. The results were presented today at the
American Thoracic Society 113th Annual Conference 2017 in
Washington, D.C.

MK-7264 is an orally-administered, non-narcotic, P2X3 receptor
antagonist. Merck plans to discuss these results and the Phase 3
clinical development plan for MK-7264 with regulatory agencies later
this year.

“There is a significant unmet need for effective treatments for chronic
cough,” said Dr. Jacky Smith, professor of respiratory medicine at the
University of Manchester and University Hospital Manchester NHS
Foundation Trust. “We are encouraged by the results of the MK-7264 study
and look forward to further evaluations of this investigational therapy.”

The randomized, double-blind, placebo-controlled, parallel group study
evaluated MK-7264 in patients (n=253) with refractory chronic cough
(chronic cough for ≥ 1 year; patients were included in the study per
ATS/BTS guidelines). Patients were randomized to receive placebo (n=63),
7.5 mg (n=63), 20 mg (n=63), and 50 mg (n=63) doses of MK-7264 twice
daily. The primary efficacy endpoint was the mean change in Awake Cough
Frequency after 12 weeks of treatment vs. baseline. Cough frequency was
measured using sound recordings obtained by a digital recording device.
Patients who received a 7.5 mg, 20 mg and 50 mg dose of MK-7264
experienced a reduction in Awake Cough Frequency from baseline compared
to placebo of 22 percent, 22 percent and 37 percent respectively; the
difference for the 50 mg dose compared to placebo was statistically
significant (p<0.05). The secondary endpoint of patient-reported Cough
Severity (0-100mm on the Visual Analog Scale) compared to baseline
showed a reduction of 15.2mm for placebo, 19.2mm for 7.5 mg, 23.4mm for
20 mg and 31.1mm for 50 mg doses.

Dysgeusia, an alteration in taste, was the most common adverse event
reported in 4.8 percent, 9.5 percent, 33.3 percent and 47.6 percent of
patients receiving placebo, 7.5 mg, 20 mg, and 50 mg of MK-7264,
respectively. Hypogeusia, reduced ability to taste, was reported in 1.6
percent, 0 percent, 17.5 percent and 23.8 percent of patients on
placebo, 7.5 mg, 20 mg, and 50 mg of MK-7264, respectively. One patient
in the placebo group and six patients in the 50 mg treatment group
discontinued due to taste-related adverse events. No patients in the 7.5
mg and 20 mg groups discontinued due to taste-related adverse events.

“These results, from the largest study to date in chronic cough, provide
evidence to continue evaluating MK-7264,” said Dr. Andrew M.
Tershakovec, executive director, clinical research, Merck Research
Laboratories. “We look forward to further discussions with regulatory
agencies this year to discuss next steps.”

About MK-7264

MK-7264 (formerly AF-219) is an investigational orally administered
non-narcotic therapeutic candidate that selectively blocks the P2X3
receptor. It is believed that excessive activation of P2X3 receptors is
associated with hyper-sensitization of sensory neurons. Neuronal
hyper-sensitization in the airways and lungs, triggered by injury or
infection, can cause an exaggerated, persistent and frequent urge to
cough, so called chronic cough.

About Chronic Cough

The prevalence of chronic cough (a cough lasting more than 8 weeks) is
estimated at ~10 percent of U.S adults. There are currently no approved
therapies for the treatment of chronic cough.

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. Through our prescription
medicines, vaccines, biologic therapies and animal health products, we
work with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies, programs
and partnerships. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
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Pamela Eisele , 267-305-3558
Kate Prout, 267-980-7601
Amy Klug, 908-740-1898

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