Anacor Pharmaceuticals Announces Positive Results From Phase 2 Dose-Ranging Study of AN2728 in Adolescents With Atopic

  Anacor Pharmaceuticals Announces Positive Results From Phase 2 Dose-Ranging
  Study of AN2728 in Adolescents With Atopic Dermatitis

 Anacor Will Host a Conference Call Today 8am ET / 5am PT to Discuss Results

Business Wire

PALO ALTO, Calif. -- March 21, 2013

Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive results from a
Phase 2 dose-ranging trial (AN2728-AD-204) of its topical boron-based
phosphodiesterase-4 (PDE-4) inhibitor, AN2728. The study included 86
adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis, a chronic
rash which predominantly affects children and is characterized by inflammation
and itching. In this study, lesions treated with AN2728 ointment, 2.0% twice
daily for 28 days achieved a 71% improvement from baseline in their Atopic
Dermatitis Severity Index (ADSI) score, with 66% of lesions in this treatment
group achieving total or partial clearance. AN2728 was generally safe and
well-tolerated. Most adverse events were mild and largely unrelated to study
drug.

“These results demonstrate a clear dose response across the four dosing
regimens and identify the AN2728 ointment, 2.0% BID dosing regimen as optimal
for a Phase 3 program, which we expect to initiate around the end of 2013,”
said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “In all
arms of the study, lesions treated with AN2728 ointment improved throughout
the 28 day treatment period. The majority of the improvement occurred within
the first week of treatment, which is important to both patients and
physicians. AN2728 also continues to demonstrate an excellent safety profile -
a key factor in treating this disease that primarily affects children.”

“There is a tremendous clinical need for safe and effective treatments for
pediatric atopic dermatitis. It is very exciting to see these promising
positive data for a novel molecule with excellent anti-inflammatory properties
and that appears very safe to use,” said Lawrence F. Eichenfield, M.D., Chief
of Pediatric and Adolescent Dermatology and Professor of Pediatrics and
Medicine (Dermatology) at Rady Children's Hospital, University of California,
San Diego. “AN2728 has the potential to be an outstanding addition to the
treatment armamentarium for physicians and a great benefit to children with
atopic dermatitis.”

The Phase 2 randomized, double-blind, bilateral study enrolled adolescent
patients with mild-to-moderate atopic dermatitis. Patients were randomized 1:1
to either once daily (QD) or twice daily (BID) application for 28 days.
Patients were instructed to apply AN2728 ointment, 2.0% to one target lesion
and AN2728 ointment, 0.5% to a comparable target lesion. The primary endpoint
was the change from baseline ADSI score, which is the sum of the severity
scores of five clinical features (erythema, pruritus, exudation, excoriation
and lichenification) from 0 (none) to 3 (severe) for each feature, for a total
score of 0 to 15. Additional endpoints included differences in ADSI component
subscores and safety.

A clear dose response was demonstrated in this study, with AN2728 ointment,
2.0% BID yielding the greatest improvement. At Day 29, the following results
were observed:

                                            
                                                          % of Lesions
Dosing Regimen         % Improvement from     Achieving Total or
                               Baseline ADSI              Partial
                                                          Clearance
AN2728 2.0%,           71%                    62%
BID
AN2728 0.5%,           62%                    50%
BID
AN2728 2.0%,           63%                    41%
QD
AN2728 0.5%,           54%                    43%
QD

               
Dosing          % Improvement in Component Score from Baseline
Regimen
               Erythema         Excoriation         Exudation         Lichenification         Pruritus
AN2728
2.0%,           67%              78%                 80%               54%                     79%
BID
AN2728
0.5%,           59%              64%                 56%               49%                     75%
BID
AN2728
2.0%,           55%              73%                 76%               46%                     73%
QD
AN2728
0.5%,           52%              57%                 52%               44%                     63%
QD
                                                                                              

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 8:00 a.m. ET / 5:00 a.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, an antifungal for the treatment of
onychomycosis, and AN2728, an 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 referred to as GSK2251052, or
GSK‘052), an antibiotic for the treatment of infections caused by
Gram-negative bacteria, which previously was licensed to GlaxoSmithKlineLLC,
or GSK. GSK has returned all rights to the compound to us and we are
considering our options for further development, if any, of this compound. We
have also discovered three other compounds that we have out-licensed for
further development — two are licensed to Eli Lilly and Company for the
treatment of animal health indications and the third compound, AN5568, also
referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases
initiative, or DNDi, for human African trypanosomiasis (HAT, or sleeping
sickness). 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.

Forward-Looking Statements

This press release may contain forward-looking statements that relate to
future events including the development 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.

Contact:

For Anacor Pharmaceuticals
DeDe Sheel, 650.543.7575
Director, Investor Relations and Corporate Communications
 
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