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March 4, 2014 5:30 pm ET

Data Presented at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI)

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced results from a Phase 2b study evaluating two doses of
its investigational house dust mite sublingual immunotherapy tablet
(MK-8237). The data were presented for the first time during a
late-breaking oral session at the 2014 Annual Meeting of the American
Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.

The study was conducted in 124 adult patients 18 years of age and older
with house dust mite-induced allergic rhinitis, with or without
conjunctivitis, using an environmental exposure chamber. In the study,
MK-8237 at once-daily doses of 6 Development Units (DU) and 12 DU
produced a significant dose- and time-dependent reduction in average
total nasal symptom score (TNSS) over the last four hours of the chamber
challenge at week 24 of treatment compared to placebo (-27%=6 DU,
-49%=12 DU; p<0.05 for both vs. placebo), the primary efficacy endpoint
of the study. TNSS is the total score for four nasal symptoms: itchy
nose, blocked nose, runny nose and sneezing.

“Merck is committed to the research and development of sublingual tablet
immunotherapy options for the treatment of allergic rhinitis,” said Dr.
Sean Curtis, vice president, Respiratory and Immunology, Merck Research
Laboratories. “We look forward to continuing with Phase 3 research,
which will provide further insight into the safety and efficacy of
MK-8237.”

Study Design

In this double-blind, single-site, Phase 2b study, 124 adults, 18 years
of age or older, with house dust mite-induced allergic rhinitis, with or
without conjunctivitis, were randomized to receive 6 DU (n=41) or 12 DU
(n=42) of MK-8237 sublingual tablets once daily for 24 weeks or placebo
(n=41). Sensitivity to house dust mite allergen was determined by
specific IgE testing. Patients with unstable uncontrolled/partially
controlled or severe asthma were excluded from the study, as were
patients with forced expiratory volume in 1 second (FEV₁) <70
percent of predicted value. Participants were exposed to the house dust
mite allergen using an environmental exposure chamber at weeks 8, 16 and
24. This method allows for controlled and reproducible conditions that
provide a constant concentration of allergen over a six-hour period with
patients recording symptoms every 15 minutes.

Study Results

Both doses of MK-8237 showed a significant dose- and time-dependent
reduction in average TNSS over the last four hours of the chamber
challenge at week 24 of treatment compared to placebo (-27%=6 DU,
-49%=12 DU; p<0.05 for both vs. placebo). Key secondary efficacy
endpoints of the study were average TNSS over the last four hours of the
chamber challenge at weeks 8 and 16 compared to placebo, and average
total symptom score (TSS) over the last four hours of the chamber
challenge at week 24 compared to placebo. TSS is the total score for
four nasal symptoms (itchy nose, blocked nose, runny nose and sneezing)
and two ocular symptoms (gritty feeling/red/itchy eyes and watery eyes).
MK-8237 demonstrated dose-dependent reductions versus placebo in average
TNSS at week 8 (-8%=6 DU; p=NS and -20%=12 DU; p<0.05) and at week 16
(-18%=6 DU, -30%=12 DU; p<0.05 for both vs. placebo). MK-8237 also
demonstrated dose-dependent reductions versus placebo in average TSS at
week 24 (-29%=6 DU, -52%=12 DU (p<0.05 for both vs. placebo).

In this study, the most common adverse events (incidence ≥ 5%) occurring
in patients receiving MK-8237 6 DU, 12 DU or placebo, respectively, were
throat irritation (34%, 52%, 0%), mouth edema (24%, 24%, 0%), lip
swelling (5%, 17%, 2%), oral pruritus (15%, 14%, 0%), dyspepsia (2%,
10%, 0%), ear pruritus (0%, 7%, 0%), swollen tongue (0%, 5%, 0%),
oropharyngeal swelling (0%, 5%, 0%) and pharyngeal edema (2%, 5%, 0%).
There were no local swellings of severe intensity and no serious adverse
events reported in patients treated with MK-8237. The majority of
adverse events in this study were assessed as mild or moderate. There
were no investigator reported systemic allergic reactions or reactions
treated with epinephrine for either dose of MK-8237.

A Phase 3 study of MK-8237 in adolescents and adults with house dust
mite-induced allergic rhinitis is currently screening patients. Details
of the study can be viewed on ClinicalTrials.gov.

Additional Merck Research Presented at AAAAI

• Efficacy of the Short-Ragweed Sublingual Immunotherapy Tablet MK-3641
  in Monosensitized and Polysensitized Subjects (Poster 756);
• The Effect of the Ragweed Sublingual Immunotherapy Tablet MK-3641 on
  Rescue Medication Use (Poster 972);
• The Efficacy and Safety of the Short-Ragweed Sublingual Immunotherapy
  Tablet MK-3641 is Similar in Asthmatic and Nonasthmatic Subjects
  Treated for Allergic Rhinitis with/without Conjunctivitis (AR/C)
  (Poster 754);
• Magnitude of Changes in Patient Symptom and Medication Scores in Grass
  Allergy Immunotherapy Trials: Dependency on Levels of Pollen Exposure
  (Poster 767).

About Merck

Today’s Merck is a global healthcare 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
consumer care 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
healthcare through far-reaching policies, programs and partnerships. For
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Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’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; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, 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 Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (www.sec.gov).

Merck
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