Data From Optimer's Second Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) Featured in Oral Presentation at Digestive Disease Week
Fidaxomicin Associated with Lower Recurrence Rates and Higher Global Cure Rates in Subjects Receiving Concomitant Antibiotics
SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- Optimer
Pharmaceuticals, Inc. (NASDAQ:OPTR) announced the presentation of new
data from its second fidaxomicin Phase 3 clinical study in patients
with Clostridium difficile infection (CDI). The data, presented by
Stuart Johnson, M.D. during an oral session at the annual meeting
of Digestive Disease Week (DDW) in New Orleans, indicated that
treatment with fidaxomicin significantly improved the recurrence
rate and global cure rate in CDI patients requiring concomitant
antibiotics, compared to vancomycin.
Many patients have persistent infections or develop new
infections during the course of CDI treatment. In these situations,
additional concomitant antibiotics often must be administered,
which can have a negative effect by increasing recurrences and
lowering global cures of CDI. In the study presented by Dr.
Johnson, 59% of subjects were receiving concomitant antibiotics
during CDI treatment. New data from analyses of the study showed
that, among subjects who were receiving concomitant antibiotics,
treatment with fidaxomicin resulted in a significantly lower
recurrence rate compared to treatment with vancomycin (17.6% vs.
29.5%, p=0.027) and an improved global cure rate compared to
treatment with vancomycin (67.5% vs. 53.4%, p=0.020). These results
confirm findings from the first fidaxomicin Phase 3 study and
suggest that, even when concomitant antibiotics are administered,
fidaxomicin may be more effective than vancomycin in the treatment
"The data presented today confirm the benefits of fidaxomicin in
CDI treatment even when patients require concomitant antibiotics, a
common scenario during CDI treatment," said Stuart Johnson, M.D.,
Infectious Disease Section, Loyola University Medical Center and
Hines VA Hospital. "More importantly, fidaxomicin is the first CDI
antibiotic treatment to show significantly lower recurrence rates
over the only FDA approved therapy for CDI."
Dr. Johnson also presented the previously announced top-line
results, baseline demographic, disease characteristics, and data
related to subgroup analysis of the BI/NAP1/027 strain and the
non-BI/NAP1/027 strains of Clostridium difficile.
Fidaxomicin Clinical Study Design
The second fidaxomicin Phase 3 clinical study was a
multi-center, randomized, double-blind clinical trial, which
enrolled 535 adult subjects. Subjects with confirmed CDI received
either fidaxomicin (200 mg q12h) or Vancocin (125 mg q6h). This
study was conducted in approximately 100 clinical sites throughout
North America and Europe. The study was designed to evaluate safety
and compare the response to treatment in subjects during and after
a 10-day course of therapy. Non-inferiority in clinical cure
(defined as patients requiring no further CDI therapy two days
after completion of study medication, as determined by the
investigator) compared to Vancocin was the primary endpoint. If
cured, subjects were monitored for a subsequent four-week period to
evaluate recurrence, which was a secondary endpoint. Global cure,
also a secondary endpoint, was defined as patients who were cured
and did not have a recurrence during this subsequent four-week
About Clostridium difficile Infection
CDI has become a significant medical problem in hospitals,
long-term care facilities, and in the community. It is a serious
illness caused by infection of the inner lining of the colon by C.
difficile bacteria, which produces toxins that cause inflammation
of the colon, severe diarrhea and, in the most serious cases,
death. Patients typically develop CDI from the use of
broad-spectrum antibiotics that disrupt normal gastrointestinal
(gut) flora, and thus allowing C. difficile bacteria to
Current therapeutic options for CDI include the off-label use of
metronidazole and oral vancomycin, the only FDA-approved treatment.
However, approximately 20% to 30% of CDI patients who initially
respond to these treatments experience a clinical recurrence
following cessation of antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic
use (such as cephalosporins and fluoroquinolones), advanced age
(over 65) and emerging hyper-virulent strains (BI/NAP1/027, 078,
001) of C. difficile. Increasing incidence, higher treatment
failures and recurrence with current therapies have resulted in
greater awareness and concern of CDI among medical professionals
and public health officials.
Fidaxomicin is the first in a new class of antibiotics called
macrocycles, which inhibit the bacterial enzyme RNA polymerase,
resulting in the death of C. difficile. The narrow-spectrum profile
of fidaxomicin may eradicate C. difficile selectively with minimal
disruption to the normal intestinal flora, while most
broad-spectrum antibiotics, including metronidazole and vancomycin,
disrupt these flora. Fidaxomicin may facilitate the return of the
normal physiological conditions in the colon and reduce the
probability of CDI recurrence.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company
focused on discovering, developing and commercializing innovative
anti-infectives to treat serious infections and address unmet
medical needs. Optimer has two late-stage anti-infective product
candidates under development. Fidaxomicin is a narrow spectrum
antibiotic being developed for the treatment of Clostridium
difficile infection. Optimer has reported positive top-line results
from two Phase 3 trials of fidaxomicin. Pruvel(TM) is a prodrug in
the fluoroquinolone class of antibiotics being developed as a
treatment for infectious diarrhea. Optimer has also successfully
completed two Phase 3 trials with Pruvel. Additional information
can be found at http://www.optimerpharma.com/.
Statements included in this press release that are not a
description of historical facts are forward-looking statements
including, without limitation, all statements related to
fidaxomicin, the incidence and anticipated effects of CDI, the
efficacy of current CDI treatments and the efficacy and potential
benefits of fidaxomicin. Words such as "believes", "anticipates",
"plans", "expects", "may", "intend", "will", "goal" and similar
expressions are intended to identify forward-looking statements.
The inclusion of forward-looking statements should not be regarded
as a representation by Optimer 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
Optimer's business including, without limitation, risks relating to
the development of alternative treatments for, or means of
preventing, CDI and other risks detailed in Optimer's filings with
the Securities and Exchange Commission.
Contacts Optimer Pharmaceuticals, Inc. Christina Donaghy, Corporate Communications Manager John D. Prunty, Chief Financial Officer & VP Finance 858-909-0736 Jason I. Spark, Senior Vice President Canale Communications, Inc. 619-849-6005
Source: Optimer Pharmaceuticals, Inc.
CONTACT: Christina Donaghy, Corporate Communications Manager, or
Prunty, Chief Financial Officer & VP Finance, +1-858-909-0736, both of Optimer
Pharmaceuticals, Inc.; or Jason I. Spark, Senior Vice President of Canale
Communications, Inc., +1-619-849-6005, for Optimer Pharmaceuticals, Inc.
Web Site: http://www.optimerpharma.com/
Posted: May 2010