Date: Dec 13, 2011 Source: (
click here to go to the source)
ast Windsor, NJ
--
December
13
, 2011
--
Aestus Therapeutics, Inc. (Aestus) today reported positive
results from a Phase II clinical stu
dy evaluating the efficacy of its novel neuropathic pain therapeutic,
ATx08
001, in the treatment of post
herpetic neuralgia (PHN). Results in patients on ATx08
001
monotherapy met the study's primary objectives of demonstrating significant analgesia in P
HN
neuropathic pain sufferers while showing an excellent safety profile.
The randomized, double
blind, placebo
controlled, multi
center study of two doses of ATx08
001 over
eight days of treatment, was designed to test the ability of ATx08
001 to relieve P
HN, the persistent pain
which often occurs after an outbreak of shingles. In the study
,
patients receiving only ATx08
001
showed a statistically significant reduction in the Mean Pain Intensity
Score (MPIS) after one week of
treatment, at both doses of AT
x08
001 tested (2.5 and 7.5 mg
bid
). This analgesic effect compares very
favorably with published results for
the standard of care medication.
"Aestus is pleased with the results showing analgesic effect of ATx08
001," stated Tage Honore, PhD,
DSc, Pres
ident and CEO of Aestus. "This is truly a remarkable result with ATx08
001, as the current
standard of care medication would need five times as many patients to achieve a comparable result in a
clinical trial. In addition, it provides very strong proof fo
r our core technology, the Aestus engine, which
produced potential therapeutics with proof
of
efficacy in patients for one
tenth of the cost in one
fifth
of the time as compared to the classical pharma R&D process."
The trial had no patients drop out of t
he study due to adverse events, or due to the need for rescue
medications. This supports the strong safety profile of ATx08
001, which has been the subject of clinical
trials in over 800 patients to date.
The clinical study, funded by a Small Business Inn
ovative Research grant to Aestus by the National
Institutes of Health's National Institute of Neurological Disorders and Stroke, provides the proof
of
efficacy for ATx08
001 necessary to justify its further development.
About Aestus Therapeutics, Inc.
A
estus Therapeutics Inc. is a translational medicine company focused on serious neurological diseases.
Capitalizing on genomic data analysis to discover novel links between these diseases and well
studied
biological pathways, Aestus identifies drug candidat
es already in clinical Phase I or later. By developing
these drugs in novel disease areas such as chronic pain, ALS and schizophrenia, Aestus greatly reduces
the time, cost and risk needed to deliver better and safer medicines for the benefit of patients a
nd
society.
www.aestustherapeutics.com
About ATx08
001
ATx08
001 is an orally available, selective PPAR
γ
modulator with an unprecedented safety and
toxicology profile. ATx08
001 is being developed by Aestus as a first
in
class treatment for neuropathic
pain, particularly for the pain associated with PHN. ATx08
001 is chemically and functionally distinct
f
rom other PPAR
γ
agonists, such as the TZD PPAR
γ
agonists, displaying a distinct target gene activation
profile and greater selectivity for PPAR
γ
than such molecules as rosiglitazone and pioglitazone.
Originally developed for the treatment of type 2 diabet
es mellitus, ATx08
001 has been examined in
Phase I and Phase II studies comprising over 800 patients, and has presented an exceptional safety
profile, particularly at the lower doses used to provide therapeutic benefit for neuropathic pain.
About NINDS p
roject support
The project described is supported by Award Number R44NS059140 from the National Institute of
Neurological Disorders and Stroke (NINDS). The content is solely the responsibility of Aestus and does
not necessarily represent the official views
of the NINDS or the National
