Pivotal Phase 3 Studies Ongoing in Treatment
of Serious Bacterial Infections
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that a Phase 2 study of relebactam, the
company’s investigational beta-lactamase inhibitor, in combination
with imipenem/cilastatin (an approved carbapenem antibiotic), in
patients with complicated urinary tract infections, met its primary
endpoint. The addition of relebactam is designed to restore
activity of imipenem against certain imipenem-resistant strains of
Gram-negative bacteria, including Pseudomonas aeruginosa and
Klebsiella pneumoniae carbapenemase (KPC)-producing
Enterobacteriaceae.
The results were presented at the American Society for
Microbiology’s ASM Microbe 2016 meeting in Boston, June 16-20.
“New medicines are urgently needed to address the growing threat
of antibiotic-resistant bacteria,” said Dr. Amanda Paschke,
director, infectious disease clinical research, Merck Research
Laboratories. “We look forward to advancing our Phase 3 clinical
program evaluating relebactam in combination with imipenem for use
in the treatment of several complicated Gram-negative bacterial
infections, and to continue to build on Merck's commitment to
addressing infectious diseases.”
In this multicenter, double-blind Phase 2 study, 302 adult
patients with complicated urinary tract infections (51.7%) or acute
pyelonephritis (48.3%) were randomized to receive either relebactam
250mg, relebactam 125mg, or placebo, each given intravenously (IV)
in combination with imipenem/cilastatin (IMI) 500mg every six hours
for 4 to 14 days. Efficacy was evaluated at discontinuation of IV
therapy (DCIV), early follow‐up, and late follow‐up. The primary
endpoint was the proportion of microbiologically evaluable patients
with a favorable microbiological response at DCIV, assessed by
non‐inferiority testing with a 15% margin. Results were similar
across treatment groups: relebactam 250mg + IMI (95.5%) (n=67),
relebactam 125mg + IMI (98.6%) (n=71), and placebo + IMI (98.7%)
(n=75). Among microbiologically evaluable patients, 10.5% (n=25)
had imipenem-resistant Gram-negative infections at baseline.
Safety analysis focused on adverse events occurring while on
intravenous study therapy or during the 14 days following the end
of therapy in all randomized patients who received at least one
dose of intravenous study therapy. The most common adverse events
(headache, diarrhea and nausea) occurred at similar rates across
treatment groups: relebactam 250mg + IMI (7.1%, 5.1%, 4.0%),
relebactam 125mg + IMI (3.0%, 2.0%, 6.1%), and placebo + IMI (4.0%,
4.0%, 4.0%), respectively.
Phase 3 Clinical Program of Relebactam/Imipenem/Cilastatin
Ongoing
Two pivotal Phase 3 clinical studies of relebactam in
combination with imipenem/cilastatin are currently ongoing and
recruiting patients. One study compares treatment with
imipenem/relebactam, as a fixed-dose combination, with
piperacillin/tazobactam in patients with hospital-acquired
bacterial pneumonia or ventilator-associated bacterial pneumonia.
The primary hypothesis of this study is that imipenem/relebactam is
non-inferior to piperacillin/tazobactam in the incidence rate of
all-cause mortality. (www.ClinicalTrials.gov Identifier:
NCT02493764)
A second study evaluates the efficacy and safety of
imipenem/relebactam versus colistimethate sodium in combination
with imipenem in the treatment of imipenem-resistant bacterial
infections, including those caused by Pseudomonas aeruginosa and
KPC-producing organisms. Infections evaluated in this study include
hospital-acquired bacterial pneumonia, ventilator-associated
bacterial pneumonia, complicated intra-abdominal infections and
complicated urinary tract infections. (www.ClinicalTrials.gov
Identifier: NCT02452047)
About Relebactam
Relebactam is an investigational, intravenous, class A and C,
beta-lactamase inhibitor currently being evaluated in combination
with imipenem/cilastatin for the treatment of certain complicated
Gram-negative bacterial infections. In preclinical studies,
relebactam administered in combination with imipenem demonstrated
antibacterial activity against a broad range of Gram-negative and
beta-lactam-resistant pathogens. The U.S. Food and Drug
Administration (FDA) has designated this combination as a Qualified
Infectious Disease Product (QIDP) with designated Fast Track status
for the treatment of hospital-acquired bacterial pneumonia,
ventilator-associated bacterial pneumonia, complicated
intra-abdominal infections and complicated urinary tract
infections.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. 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. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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
management and are subject to significant risks and uncertainties.
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
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
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protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2015
Annual Report on Form 10-K and the company’s other filings with the
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Internet site (www.sec.gov).
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