Santarus, Inc. (NASDAQ: SNTS) today announced that its Phase III
clinical study to evaluate the safety and efficacy of the
investigational drug, rifamycin SV MMX®, met the primary
endpoint of reducing time to last unformed stool (TLUS) in patients with
travelers’ diarrhea.
In the intent-to-treat (ITT) population (n=264), the median TLUS was
46.0 hours for rifamycin SV MMX (n=199) compared with 68.0 hours for
placebo (n=65), p = 0.0008. Results in the per protocol population
(n=240) were similar to the ITT population.
Rifamycin SV MMX was generally well tolerated in this Phase III clinical
study and the frequency of treatment emergent adverse events was similar
to placebo. The most frequent treatment emergent adverse events
experienced by ≥ 2% of patients in either treatment group were: headache
(8.0% in active arm and 9.2% in the placebo arm), diarrhea (5.0% in the
active arm and 9.2% in the placebo arm), infectious diarrhea (5.0% in
the active arm and 7.7% in the placebo arm), constipation (3.5% in the
active arm and 1.5% in the placebo arm), amoebic dysentery (0% in the
active arm and 3.1% in the placebo arm) and gastrointestinal infection
(0% in the active arm versus 3.1% in the placebo arm). There were three
patients who experienced serious adverse events, all of which were
assessed by the investigator as not related to the study drug. One
patient in the placebo group developed clostridium difficile colitis and
two patients in the rifamycin SV MMX group experienced a total of three
adverse events: neuroblastoma, abdominal pain and vomiting. Santarus
expects additional data from this clinical study will be presented at an
appropriate medical meeting in 2013.
Santarus licensed rights to develop and commercialize rifamycin SV MMX
in the U.S. from Cosmo Technologies Limited. Dr. Falk Pharma GmbH,
Cosmo’s European development partner, is conducting a second Phase III
clinical study to evaluate the efficacy of rifamycin SV MMX versus
ciprofloxacin with the primary endpoint of TLUS in patients with
travelers’ diarrhea. This non-inferiority study is expected to enroll
approximately 1,000 patients and to be completed in mid-2013. Assuming
positive results in the second Phase III clinical study, Santarus and
Dr. Falk plan to share the clinical data from their respective Phase III
studies for inclusion in each company’s regulatory submissions.
“These favorable Phase III results in travelers’ diarrhea represent a
significant positive milestone in the clinical development of rifamycin
SV MMX for the U.S. market. Rifamycin SV is an investigational broad
spectrum, non-systemic antibiotic that has been used for more than 20
years in Europe in both intravenous and intramuscular forms, but is
considered a new chemical entity in the U.S.,” said Wendell Wierenga,
Ph.D., executive vice president, research and development of Santarus.
“As we wait for completion of the second ongoing Phase III study being
conducted by Dr. Falk Pharma, we plan to assess our options to evaluate
rifamycin SV MMX in other indications where a non-systemic antibiotic
with a broad spectrum of activity may offer a clinical benefit.”
About the Rifamycin SV MMX Phase III Clinical Study
The Phase III clinical study enrolled 264 patients, 65 patients on
placebo and 199 patients on rifamycin SV MMX, in an international
multicenter, randomized, double-blind, placebo-controlled trial to
assess the efficacy and safety of rifamycin SV MMX. The dosing regimen
was 400 mg (two oral tablets of 200 mg each) taken twice daily (800 mg
total daily dose) of rifamycin SV MMX or placebo for three days in the
treatment of patients with travelers’ diarrhea. The primary endpoint of
TLUS was defined as the time (hours) between the administration of the
first dose of study drug and the time that the last unformed stool was
passed before the start of clinical cure. Clinical cure was defined in
the study protocol as:
-
The passage of two or fewer soft stools and no watery stools, no fever
(>100.4°F or 38°C), and no symptoms of enteric infection (other than
mild excess gas/flatulence) during a 24-hour interval in the 120-hour
data collection period after the first dose of study drug; or
-
The passage of no stools or only formed stools and no fever during a
48-hour interval in the 120-hour data collection period after the
first dose of study drug, with or without other signs of symptoms of
enteric infection.
Additional information about the Phase III study is available here
from clinicaltrials.gov.
Rifamycin SV MMX
Rifamycin SV MMX utilizes proprietary MMX colonic delivery technology,
which consists of a sequence of lipophilic and amphiphilic matrices
dispersed within a hydrophilic matrix. MMX tablets are coated with
gastro-resistant polymers that protect the active pharmaceutical
ingredient (API) against degradation in the upper gastrointestinal tract
and delay the release of the API until the tablet reaches the colon.
Rifamycin SV MMX is covered by two issued U.S. patents that expire in
2020 and 2025.
Travelers’ Diarrhea/Intestinal Infections
Intestinal infections are caused by bacteria, viruses
or parasites.
A common infection of the intestine is travelers’ diarrhea, which is
primarily caused by the ingestion of food or water contaminated by
pathogenic strains of bacteria. According to the U.S. Centers for
Disease Control and Prevention, each year between 20% and 50% of
international travelers (an estimated 10 million people) develop
diarrhea, primarily caused by bacteria.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on
acquiring, developing and commercializing proprietary products that
address the needs of patients treated by physician specialists. The
company's current commercial efforts are focused on GLUMETZA®
(metformin hydrochloride extended release tablets) and CYCLOSET®
(bromocriptine mesylate) tablets, which are indicated as adjuncts to
diet and exercise to improve glycemic control in adults with type 2
diabetes, and on FENOGLIDE®
(fenofibrate) tablets, which is indicated as an adjunct to diet to
reduce high cholesterol.
Santarus has a diverse product development pipeline. A New Drug
Application for UCERIS™ (budesonide) tablets for induction of
remission of active, mild to moderate ulcerative colitis is under review
by the U.S. Food and Drug Administration with a response expected in
January 2013. The pipeline also includes two late-stage investigational
drugs in Phase III clinical studies: RUCONEST® (recombinant
human C1 esterase inhibitor) for treatment of acute attacks of
hereditary angioedema and rifamycin SV MMX® for treatment of
travelers’ diarrhea. In addition, the company’s investigational
monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical
program. More information about Santarus is available at www.santarus.com.
Santarus cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. For example, statements regarding the timing of the
Dr. Falk Phase III clinical study of rifamycin SV MMX, the potential for
ultimate FDA approval and anticipated patent protection are
forward-looking statements.
The inclusion of forward-looking statements should not be regarded as
a representation by Santarus that any of its plans will be achieved. Actual
results may differ materially from those set forth in this release due
to the risks and uncertainties inherent in Santarus’ business,
including, without limitation: Santarus' ability to successfully develop
rifamycin SV MMX in a timely manner or at all; whether the Dr. Falk
Phase III clinical study is completed in a timely and successful manner;
whether Santarus is able to obtain regulatory approval for rifamycin SV
MMX in a timely manner or at all, including whether the FDA agrees with
the clinical interpretation of the results and the conduct of the
studies; risks associated with the license agreement with Cosmo relating
to rifamycin SV MMX, including the potential for termination of the
agreement; competition from other products; unexpected adverse side
effects or inadequate therapeutic efficacy; the scope and validity of
patent protection for rifamycin SV MMX; other difficulties or delays in
development, testing, manufacturing and marketing of, and obtaining and
maintaining regulatory approvals for, Santarus’ products; and other
risks detailed in Santarus’ prior press releases as well as in public
periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Santarus undertakes no obligation to revise or
update this news release to reflect events or circumstances after the
date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.
Santarus®, FENOGLIDE®
and UCERIS™ are trademarks of Santarus, Inc.
GLUMETZA® is a trademark of Biovail
Laboratories International S.r.l. licensed exclusively in the United
States to Depomed, Inc. CYCLOSET® is a
trademark of VeroScience LLC. MMX® is a
trademark of Cosmo Technologies Limited. RUCONEST®
is a trademark of Pharming Group N.V.
