FARA Press Release

FOR IMMEDIATE RELEASE
EPI-A0001 Improves Neurological Outcome Endpoint in 28-Day Phase 2A
Double-Blind Placebo-Controlled Clinical Trial in Friedreich's Ataxia
Clinical trial being designed to confirm encouraging results
FARA, June 11, 2011 – In its release issued Friday, Edison
Pharmaceuticals, Inc.
announced that EPI-A0001 significantly improved neurological function as
assessed by the
Friedreich's Ataxia Rating Scale (FARS). The trial did not show
significant improvement in
the primary endpoint of glucose disposition index (a measure of the
body's glucose
handling). The three arms of the trial consisted of placebo, low dose
and high dose of
EPI-A0001. The FARS scores improvements were reported to be
statistically significant in
both the low and high dose groups when compared to the placebo group.
There were no
differences between the placebo group and the two drug-treated groups in
the rates of
drug-related adverse events.
Dr. David Lynch, the principal investigator of the trial, said, "We are
working closely with
Edison, the U.S. Food and Drug Administration (FDA) and our colleagues
in FARA's
Collaborative Clinical Research Network in Friedreich's Ataxia to design
extended duration
clinical trials to verify this encouraging data." FARA President Ron
Bartek added, "FARA
would like to thank the patients and patient families who participated
in this very
promising clinical trial. We look very much forward to working with the
FA patient
community, Edison and the clinical investigators as EPI-A0001 takes its
next steps through
clinical development toward the treatment goal for which we are all
striving together."
FARA has been involved in the development of EPI-A0001 from its
pre-clinical
development stage. In 2006, Dr. Robert B. Wilson, Edison Pharmaceuticals
and FARA as
co-applicants were accepted into the National Institutes of Health Rapid
Access to
Intervention Development (RAID) Pilot Program. Support by this NIH
program accelerated
EPI-A0001 clinical development. Additionally, FARA has awarded multiple
grants to Edison
for the development of both EPI-A0001 and EPI-743. FARA will continue
working hand-inhand
with Edison, the investigator team, and the patient and physician
community to
begin implementation of further EPI-A0001 prospective trials.
About FA
FA is a rare, degenerative, life-shortening neuro-muscular disorder that
affects children
and adults and involves the loss of strength and coordination usually
leading to wheelchair
use; diminished vision, hearing and speech; scoliosis (curvature of the
spine); increased
risk of diabetes, and a life-threatening heart condition. There are
currently no effective
treatments.
About FARA
The Friedreich's Ataxia Research Alliance (FARA) is a 501(c)(3),
non-profit, charitable
organization dedicated to accelerating research leading to treatments
and a cure for
Friedreich's ataxia. www.CureFA.org
Contact:
Jennifer Farmer
Executive Director, Friedreich's Ataxia Research Alliance
(484) 879 6160
info@curefa.org