Anacor Pharmaceuticals Announces Positive Results From Phase 2 Trial of
AN2728 in Adolescents With Atopic Dermatitis
Anacor Will Host a Conference Call Today at 5pm ET / 2pm PT to Discuss Results
PALO ALTO, Calif. -- December 10, 2012
Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive results from a
Phase 2 safety, pharmacokinetics (PK), and efficacy trial of its boron-based
phosphodiesterase-4 (PDE-4) inhibitor, AN2728, in adolescents (ages 12 – 17)
with mild-to-moderate atopic dermatitis, a chronic rash characterized by
inflammation and itching.
“Data from our first study of AN2728 in adolescents with atopic dermatitis are
promising, with 35% of patients achieving an ISGA score of ‘clear’ or ‘almost
clear’ with a minimum 2-grade improvement. This is the first study in which we
have evaluated the effect of treating all of a patient’s atopic dermatitis and
measured the improvement using the ISGA scale, the same scale used by the FDA
to evaluate the most recently approved topical treatments for atopic
dermatitis,” said David Perry, Anacor’s Chief Executive Officer. “In addition,
AN2728 demonstrated a promising safety profile in a younger patient
population, which is essential given that this disease primarily affects
The Phase 2 open-label study enrolled 23 adolescent patients, with
mild-to-moderate atopic dermatitis involving 10-35% of treatable body surface
area (BSA). Mild-to-moderate atopic dermatitis was defined as an Investigator
Static Global Assessment (ISGA) score of 2 (“mild”) or 3 (“moderate”). The
ISGA is a 5-point scale from 0 (“clear”) to 4 (“severe”). Patients were
instructed to apply AN2728, 2% ointment twice daily for 28 days. The primary
endpoints were an assessment of safety and tolerability based on the frequency
and severity of systemic and local adverse events (AE’s) as well as the
pharmacokinetic profile. Secondary endpoints included assessment of change in
ISGA score as well as individual signs and symptoms of atopic dermatitis.
*74% of patients achieved an ISGA score of 0 (“clear”) or 1 (“almost
clear”) after four weeks of treatment.
*35% of patients achieved an ISGA score of 0 (“clear”) or 1 (“almost
clear”) with a minimum 2-grade improvement after four weeks of treatment.
*In addition to the improvement in ISGA score, treatment with AN2728 also
led to improvement in all of the individual signs and symptoms of atopic
Safety and Tolerability
*AN2728 was generally safe and well-tolerated with the most common AE’s
being application site reactions.
*Overall blood levels in adolescents were low and were similar to those
previously observed in adults after adjusting for percent BSA treated.
Development Plan for AN2728 in Atopic Dermatitis
*We are currently conducting a Phase 2 dose-ranging study in adolescents
with atopic dermatitis and expect results from this study in the first
half of 2013.
*We plan to initiate a Phase 2 study in children under the age of 12 in the
first half of 2013.
*We plan to initiate Phase 3 studies in atopic dermatitis pending the
results of the two Phase 2 studies described above.
About Atopic Dermatitis and Current Treatment Options
Atopic dermatitis is a chronic rash characterized by inflammation and itching.
In 2007, Datamonitor reported that atopic dermatitis affected approximately
40million people across the seven major pharmaceutical markets. The condition
most commonly appears in childhood, with up to 20% of children in the United
States affected, and it can persist into adulthood. Skin affected by atopic
dermatitis can often be broken from scratching which can allow bacterial or
viral access and lead to secondary infections. Current atopic dermatitis
treatments attempt to reduce inflammation and itching to maintain the
protective integrity of the skin. Antibiotics, antihistamines, topical
corticosteroids and topical immunomodulators, either as monotherapy or in
combination, are the current standard of care for atopic dermatitis. However,
these can be limited in utility due to insufficient efficacy, side effects or
safety concerns. The most recently approved novel topical treatments for
atopic dermatitis were topical immunomodulators, Protopic (tacrolimus) and
Elidel (pimecrolimus), approved in 2000 and 2001, respectively. Protopic and
Elidel achieved combined sales of over $500 million in 2004, prior to
receiving Black Box warnings from the FDA in early 2005.
Conference Call and Webcast
Anacor will host a conference call today at 5:00 p.m. ET / 2:00 p.m. PT to
discuss the results of this Phase 2 trial in atopic dermatitis. The call can
be accessed by dialing (877) 291-1367 (domestic) and (914) 495-8534
(international) five minutes prior to the start of the call. The call will
also be webcast live and can be accessed on the Events and Presentations page,
under Investors, on the company’s website at www.anacor.com and will be
available for three months following the call.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and
commercializing novel small-molecule therapeutics derived from its boron
chemistry platform. Anacor has discovered eight compounds that are currently
in development. Its two lead product candidates are topically administered
dermatologic compounds — tavaborole, a topical antifungal for the treatment of
onychomycosis, and AN2728, a topical anti-inflammatory PDE-4 inhibitor for the
treatment of atopic dermatitis and psoriasis. In addition to its two lead
programs, Anacor has discovered three other wholly-owned clinical product
candidates — AN2718 and AN2898, which are backup compounds to tavaborole and
AN2728, respectively, and AN3365 (formerly known as GSK2251052, or GSK‘052),
a systemic antibiotic for the treatment of infections caused by Gram-negative
bacteria, which previously was licensed to GlaxoSmithKlineLLC, or GSK. GSK
will be returning all rights to the compound to us and we are considering our
options for further development, if any, of this compound. We have discovered
three other compounds that we have out-licensed for further development — two
compounds for the treatment of animal health indications that are licensed to
Eli Lilly and Company and AN5568, also referred to as SCYX-7158, for human
African trypanosomiasis (HAT, or sleeping sickness), which is licensed to
Drugs for Neglected Diseases initiative, or DNDi. We also have a pipeline of
other internally discovered topical and systemic boron-based compounds in
development. For more information, visit http://www.anacor.com.
This press release may contain forward-looking statements that relate to
future events including the development and commercialization of AN2728, the
representative nature of the Phase 2 study and reported results as indicative
of future clinical trials in support of regulatory approval, and the timing
and potential for initiation, enrollment and conduct of future trials of
AN2728 in atopic dermatitis. These forward looking statements 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, including risks
related to enrollment and successful completion of our trials, risk of
unforeseen side effects and risks related to regulatory approval of new drug
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.
DeDe Sheel, 650-543-7575
Director, Investor Relations and Corporate Communications
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