Merck Announces Top-Line Results from Phase 3 Trials Evaluating Gefapixant, an Investigational Treatment for Refractory or Un...
March 17 2020 - 6:45AM
Business Wire
Gefapixant (45 mg Twice Daily) Demonstrated
Statistically Significant Decrease in 24-hour Coughs Per Hour
Compared to Placebo at Week 12 and 24 in Phase 3 Trials
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced top-line efficacy results from two ongoing
pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating the
efficacy and safety of gefapixant (MK-7264), an investigational,
orally administered, selective P2X3 receptor antagonist, for the
treatment of refractory or unexplained chronic cough. In these
studies, the primary efficacy endpoints were met for the gefapixant
45 mg twice daily treatment arms – demonstrating a statistically
significant decrease in 24-hour coughs per hour (average hourly
cough frequency based on 24-hour sound recordings) versus placebo
at 12 (COUGH-1) and 24 weeks (COUGH-2). The gefapixant 15 mg twice
daily treatment arms did not meet the primary efficacy endpoint in
either Phase 3 study. The safety and tolerability profile of
gefapixant during the trials to date is consistent with the
previously reported Phase 2 study. The trials will continue for
long-term follow-up to collect additional safety data.
“The burden for patients faced with this disease underscores the
need for effective therapeutic options for refractory and
unexplained chronic cough,” said Dr. Roy Baynes, senior vice
president and head of global clinical development, chief medical
officer, Merck Research Laboratories. “We are pleased gefapixant at
the 45 mg dose met the primary efficacy endpoints in both Phase 3
studies and we look forward to sharing the detailed findings at an
upcoming medical meeting.”
About COUGH-1 and COUGH-2
COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are
international Phase 3, randomized, double-blind,
placebo-controlled, studies to evaluate the efficacy and safety of
gefapixant in reducing cough frequency in adult participants with
refractory or unexplained chronic cough. COUGH-1 enrolled 732
participants and COUGH-2 enrolled 1,317 participants, with
refractory or unexplained chronic cough for at least one year, as
defined by guidelines from the American College of Chest Physicians
(ACCP). In both studies, patients were randomized to one of three
groups: gefapixant 45 mg twice daily, gefapixant 15 mg twice daily,
or placebo. Participants remained on their assigned treatment at
randomization throughout both studies. The primary efficacy
outcomes measure for COUGH-1 and COUGH-2 were 24-hour coughs per
hour at Week 12, and 24-hour coughs per hour at week 24,
respectively, measured using an ambulatory digital audio recording
device. Secondary endpoints in both trials included awake coughs
per hour, percentage of participants with a greater than 1.3-point
increase from baseline in the Leicester Questionnaire (LCQ) total
score, and percentage of participants with a greater than 30%
reduction from baseline in 24-hour coughs per hour. COUGH-1 had a
12-week treatment period and a 40-week extension period, while
COUGH-2 had a 24-week treatment period and a 28-week extension
period. Primary safety outcomes include the percentage of patients
experiencing greater than one adverse event during treatment and
follow up, and the percentage of patients discontinuing treatment
because of adverse events.
About Gefapixant
Gefapixant is an investigational, orally administered, selective
P2X3 receptor antagonist, for the treatment of refractory or
unexplained chronic cough. 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, otherwise known as chronic
cough.
About Chronic Cough
The prevalence of chronic cough (a cough lasting more than 8
weeks) is estimated at 10% of the general adult population
globally, and in up to 46% of these cases, no treatable cause can
be identified despite a thorough diagnostic investigation. There
are currently no approved therapies for the treatment of chronic
cough.
About Merck
For more than 125 years, Merck, 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 in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
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There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
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including interest rate and currency exchange rate fluctuations;
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future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
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