Merck Announces Presentation of Phase 2 Results for MK-7264, an Investigational, P2X3 Receptor Antagonist, Being Evaluated fo...
May 22 2017 - 11:20AM
Business Wire
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,
visit www.merck.com and connect with us
on Twitter, Facebook, Instagram, YouTube
and LinkedIn.
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