AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes
14 Abril 2008 - 8:00AM
Marketwired
ATLANTA, GA , a pharmaceutical company focused on the treatment
of chronic inflammatory diseases, today released topline results
from a planned interim analysis of its ongoing ANDES Phase 3
clinical trial of AGI-1067 for the treatment of Type 2 diabetes.
ANDES is evaluating two dose levels of AGI-1067 given once daily
over six months. The primary efficacy endpoint is changed in
hemoglobin A1c (A1c) from baseline compared to placebo in patients
with Type 2 diabetes.
The interim analysis of 806 patients who completed three months
in the study showed dose-related, statistically significant
reductions in A1c. The mean changes for patients in the 150 mg, 75
mg, and placebo arms were 0.5 percent, 0.3 percent, and 0.1 percent
respectively, (p < 0.001 for 150 mg versus placebo, p=0.001 for
75 mg versus placebo).
"The ANDES trial is ongoing and we must await final data before
drawing firm conclusions," commented Alexander Fleming, M.D.,
Acting Chief Medical Officer. "We are encouraged by these early
results, which show a meaningful reduction in blood sugar for
patients with diabetes taking AGI-1067. The interim data also
suggest that this three month assessment may not be capturing the
full effect of AGI-1067 on A1c reduction, which is the standard
clinical measure of blood sugar control."
"These interim results reinforce our belief that AGI-1067 may
have the potential to introduce a new therapeutic approach for the
treatment of patients with diabetes," said Russell M. Medford,
M.D., Ph.D., President and Chief Executive Officer at AtheroGenics.
"We believe these results are sufficiently promising to allow for
the planning of a second registration study. We plan to work with
the FDA to gain their concurrence on the design of the next
study."
Based on a preliminary review of the safety data, AGI-1067 was
well-tolerated. The interim analysis showed no difference in
discontinuations between groups receiving active drug and placebo.
There has been one unexplained case of elevated liver enzymes
greater than five times the upper limit of normal in each of the
drug arms. These cases consisted only of moderate enzyme elevations
without increases in bilirubin. The liver enzyme elevations either
have resolved or are resolving. Because of the small number of
these incidents, no conclusions should be drawn regarding
AGI-1067's effect on the liver in the ANDES study until final data
are available. An independent Data Safety and Monitoring Board
recently reviewed these and other data from the clinical trial and
recommended that the trial continue to completion.
ANDES Trial Design
The primary endpoint of ANDES (AGI-1067 as a Novel anti-Diabetic
agent Evaluation Study) is an improvement in A1c at six months,
evaluating two doses of AGI-1067 (75 mg and 150 mg) compared to
placebo, on a background of one or no other oral anti-diabetes
medicines. A total of 999 patients were enrolled in the ANDES
study, including 887 in the current three-arm protocol. The
pre-planned interim analysis measured A1c levels in at least ninety
percent of ANDES patients when they had completed three months of
dosing. Final results of the study are expected in the second half
of this year.
About AGI-1067
AGI-1067 is novel oral drug candidate with demonstrated
anti-inflammatory and antioxidant properties. AGI-1067 works by
selectively inhibiting signaling pathways that are activated in
response to oxidative stress and pro-inflammatory stimuli.
Oxidative stress and inflammation have been implicated as playing a
key role in the pathogenesis of insulin resistance and
diabetes.
About AtheroGenics
AtheroGenics is focused on the discovery, development and
commercialization of novel drugs for the treatment of chronic
inflammatory diseases, including diabetes and coronary heart
disease (atherosclerosis). The Company's lead antioxidant and
anti-inflammatory drug candidate, AGI-1067, is being studied in a
Phase III clinical trial known as ANDES (AGI-1067 as a Novel
Anti-Diabetic Agent Evaluation Study), for the treatment of
diabetes. In addition, the Company has other clinical and
preclinical anti-inflammatory compounds, including AGI-1096, an
oral agent for the prevention of organ transplant rejection. For
more information about AtheroGenics, please visit
http://www.atherogenics.com.
Teleconference and Webcast
AtheroGenics will host a conference call on Monday, April 14,
2008 at 9:00 a.m. Eastern Daylight Time to discuss the top-line
interim results of the ANDES Phase 3 clinical trial.
Conference Call Details:
Dial-In:
(877) 407-8031 (U.S.)
(201) 689-8031 (International)
To access the conference call replay, please dial (877) 660-6853 (U.S.)
or (201) 612-7415 (International), Conference ID: 281135; Account #286.
The conference call replay will be available through May 13, 2008.
Webcast:
To access the webcast, please go to
http://www.atherogenics.com/investor/index.html.
The webcast will be available through May 13, 2008 on AtheroGenics'
website www.atherogenics.com.
Disclosure Regarding Forward-Looking Statements
Statements contained in this press release that relate to events
or developments that we expect or anticipate will occur in the
future are deemed to be forward-looking statements, and can be
identified by words such as "believes," "intends," "expects" and
similar expressions. AtheroGenics cautions investors not to place
undue reliance on the forward-looking statements contained in this
release. Examples of forward looking statements in this press
release include (i) our expectation that the interim analysis may
not be capturing the full effect of AGI-1067 on A1c reduction, (ii)
our belief that AGI-1067 may have the potential to introduce a new
therapeutic approach for the treatment of patients with diabetes,
and (iii) our expectation that final study results will be
available in the second half of 2008. These and other such
statements are subject to certain factors, risks and uncertainties
that may cause actual results, events and performances to differ
materially from those referred to in such statements. For example,
additional information relating to the safety, efficacy or
tolerability of AGI-1067, may be discovered upon further analysis
of trial data. The U.S. Food and Drug Administration might not
allow us to conduct further studies of the efficacy of AGI-1067 for
the same or new endpoints, and, to the extent approved, additional
clinical trial work may take a significant period of time to
complete or require significant additional resources to complete.
We cannot ensure that AGI-1067 will ever be approved or be proven
safe and effective for use in humans. These and other risks are
discussed in AtheroGenics' Securities and Exchange Commission
filings, including, but not limited to, the risks discussed in
AtheroGenics' Annual Report on Form 10-K for the fiscal year ended
December 31, 2007 and are specifically incorporated by reference
into this press release. We undertake no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise.
CONTACTS: AtheroGenics, Inc. Mark P. Colonnese Executive Vice
President 678-336-2511 Email Contact Media Inquiries Jayme Maniatis
/ Dana Conti Schwartz Communications, Inc. 781-684-0770 Email
Contact Investor Inquiries Lilian Stern Stern Investor Relations,
Inc. 212-362-1200 Email Contact
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