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Anacor Pharmaceuticals Announces Positive Results
from Phase 2a Clinical Trial of AN2728 in Psoriasis Patients
Palo Alto, Calif.
March 25, 2008
Anacor
Pharmaceuticals today announced results from a Phase 2a clinical
trial of AN2728, an investigational topical anti-inflammatory
drug, in patients with psoriasis. The study met its primary endpoint
and
all secondary endpoints.
In 69 percent of patients, the area treated
with AN2728 scored better at the end of therapy than the area
treated with the vehicle
ointment, compared with six percent of patients in whom the vehicle-treated
areas were superior. These results were statistically significant
(p<0.001). No drug-related safety issues were reported.
"The results of this study suggest that AN2728 can effectively
treat psoriasis in a clinical setting. In addition, plaques treated
with AN2728 continued to improve over the course of the 28 days
of therapy, suggesting longer-term treatment may have an even greater
effect," said Karl R. Beutner, M.D., Ph.D., Senior Vice President
and Chief Medical Officer of Anacor. "These results are encouraging
for both AN2728 and our entire anti-inflammatory program."
AN2728
is a novel boron-containing small molecule that inhibits the
release of pro-inflammatory cytokines including TNF-alpha, IL-12,
and IL-23, known mediators of the inflammation associated with
psoriasis.
The randomized, double-blind, placebo-controlled
trial was designed to evaluate the safety and efficacy of an ointment
containing a
5% concentration of AN2728 with patient self-application. Patients
with psoriasis commonly have similar areas of psoriasis on their
left and right, or front and back sides. The study took advantage
of this bilateral characteristic of psoriasis. In this trial,
35
patients treated one of their areas of psoriasis with AN2728 ointment,
and a matching area on the opposite side with vehicle alone, twice
a day for four weeks.
In addition to this Phase 2a study, two Phase
1b dose-ranging trials have investigated the effects of concentration
and formulation on
drug efficacy. These earlier trials demonstrated significant activity
even at a 0.5% concentration of AN2728, the lowest concentration
tested.
About Psoriasis
Affecting approximately 10 million people worldwide, psoriasis
is an inflammation of the skin caused by a reaction of the immune
system. It is characterized by thickened patches of inflamed,
red skin covered with thick, silvery scales typically found
at
the elbows, knees, scalp and genital areas.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company developing novel small molecule
therapeutics derived from its boron chemistry platform. Anacor
has focused initially on developing topical applications of
its compounds to treat fungal, bacterial and inflammatory diseases.
Anacor's most advanced product candidate is AN2690, a novel
topical
antifungal in development for the treatment of toenail onychomycosis,
which is a fungal infection of the nail and nail bed. Anacor
entered into a worldwide license, development and commercialization
agreement
for AN2690 with Schering-Plough for all indications including
the treatment of onychomycosis. Anacor also has a research and
development collaboration with GlaxoSmithKline for the discovery,
development, manufacture and worldwide commercialization of
novel systemic therapeutics for viral and bacterial diseases
utilizing
Anacor's boron-based chemistry. For more information visit www.anacor.com.
Forward-Looking
Statements
This press release contains forward-looking statements, including
statements regarding the progress and timing of our clinical
trials and the safety and efficacy of our product candidates.
These statements
relate to future events and involve known and unknown risks,
uncertainties and other factors that could cause actual levels
of activity,
performance or achievement to differ materially from those expressed
or implied by these forward-looking statements. Some factors
that may affect these forward-looking statements include, but
are not
limited to, delays in the completion of our clinical trials,
clinical failure at later stages of development and undesirable
effects
from our product candidates. These statements reflect the views
of Anacor as of the date of this press release with respect
to future events and, except as required by law, it undertakes
no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future
events or otherwise
after the date of this press release.
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