AtheroGenics Reports Clinical Data on Novel Anti-Inflammatory Anti-Oxidant Agent, AGI-1067, at American Diabetes Association Annual Meeting
AtheroGenics, Inc. (NASDAQ: AGIX) today announced that data from its 6,144-patient ARISE Phase 3 clinical study of AGI-1067 (succinobucol) were presented at the 68th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California. The ADA's annual Scientific Sessions meeting is the largest gathering of health care professionals involved in diabetes research and the delivery of diabetes care.
Results were reported from the Company's ARISE trial of patients with cardiovascular disease, approximately one-third of whom had a previous diagnosis of diabetes. The trial showed that the patients who did not have diabetes when beginning treatment and assigned to the AGI-1067 dosage group benefited by a 63% reduction in progression to new onset diabetes, compared to the patients receiving placebo. Those patients without diabetes at the beginning of the trial, but whose tests showed a pre-diabetes state referred to as impaired fasting glucose, showed a 60% reduction in progression to diabetes. These findings were presented in a Late Breaking Clinical Study oral presentation entitled, "Delay in Progression to Type 2 Diabetes in Patients with Cardiovascular Disease Treated with a Novel Anti-Inflammatory, Anti-Oxidant, AGI-1067: Evidence from ARISE" [ADA session number LBCS-01], by lead author Jean-Claude Tardif, M.D., ARISE Co-Principal Investigator and Director of Research, Professor of Medicine, Montreal Heart Institute, University of Montreal.
A poster presentation [Abstract 443-P] by lead author and ARISE clinical investigator, Eric Klug, M.D., Sunninghill Hospital, Gauteng, South Africa, highlighted the therapeutic effects of AGI-1067 in the diabetes patients in ARISE. Clinically significant improvements in glycemic control were seen over a one year treatment period with AGI-1067 in patients already taking commonly used anti-diabetes medications. In an analysis of 2,271 diabetes patients, 31% more patients on AGI-1067 achieved the ADA goal of hemoglobin A1c (A1c) below 7 %, compared to placebo. A1c is the accepted standard for measuring control of blood glucose. Diabetes patients in the AGI-1067 group experienced an A1c reduction of 0.5% from a baseline A1c level of 7.2%. The reduction was more pronounced in patients with higher A1c levels at baseline. AGI-1067 also caused a reduction in insulin resistance, as measured by changes in HOMA-IR levels, at both one month and 12 months. These results support the potential benefit of this novel anti-inflammatory anti-oxidant approach to treating patients with Type 2 diabetes. Patients receiving AGI-1067 had no significant increases in edema, weight gain or hypoglycemia.
"The unique mechanism of action and encouraging effects on glycemic control with AGI-1067, when used in combination with existing oral anti-diabetic treatments or insulin, support its potential as a future treatment option for patients," said Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. "We are looking forward to gaining additional insight into AGI-1067's impact on controlling blood sugar when final results from the ANDES Phase 3 clinical trial of AGI-1067 in diabetes are available in the third quarter of this year."
AGI-1067 is novel oral drug candidate that is currently in Phase 3 clinical development for the treatment of Type 2 diabetes. 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.
AtheroGenics is focused on the discovery, development and commercialization of potential drug candidates 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 3 clinical trial known as ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study), for the treatment of Type 2 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.
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. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, 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.