AtheroGenics Announces New ARISE Diabetes Data on AGI-1067 Presented at the European Society of Cardiology Congress 2007
September 05, 2007: 07:00 AM EST
AtheroGenics, Inc. (NASDAQ: AGIX), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced the presentation of new scientific data from its ARISE Phase III clinical outcomes study of its lead oral anti-diabetic drug candidate, AGI-1067, at the European Society of Cardiology Congress 2007. The data were presented today by Marc A. Pfeffer, M.D., Ph.D., Professor of Medicine, Harvard Medical School, Cardiologist at Brigham and Women's Hospital, in a Hotline & Clinical Update session.
The data showed that at 12 months AGI-1067 significantly lowered levels of glycated hemoglobin A1c (A1c), a commonly used measure of glycemic control. There was greater improvement in A1c in subjects with higher baseline A1c levels. This effect was seen in patients with or without diabetes. In addition, the data showed a marked reduction of 59 percent (p < 0.0001) in the development of new onset diabetes in patients with impaired fasting glucose (IFG), a condition which is a precursor to diabetes. In patients with diabetes, treatment with AGI-1067 also demonstrated a 22 percent (p=0.062) reduction in hard cardiovascular events of cardiovascular death, cardiac arrest, myocardial infarction and stroke. AGI-1067 also led to a meaningful increase in kidney function as indicated by the estimated glomerular filtration rate (eGFR), an accepted measure of renal function.
"We believe that the unique mechanism of action for AGI-1067 may provide multiple therapeutic benefits for patients with diabetes," commented Rob Scott, M.D., Executive Vice President of Research & Development and Chief Medical Officer. "AtheroGenics is focused on the ANDES clinical trial to confirm the beneficial effect of AGI-1067 on glycemic control as the next step in clinical development for the agent."
Patient recruitment is currently underway in the Company's Phase III clinical trial called ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study) to study AGI-1067 as an oral therapy for the treatment of diabetes.
AGI-1067 has demonstrated efficacy in over 2,200 diabetic subjects showing improvements in glycemic control. This effect with AGI-1067 has been confirmed in other clinical and preclinical studies. Oxidative stress and inflammation have been demonstrated to play a central role in the pathogenesis of insulin resistance and diabetes. AGI-1067 is an anti-inflammatory antioxidant agent that works by inhibiting signaling pathways that are activated in response to oxidative stress and pro-inflammatory stimuli.
AGI-1067 has been evaluated in numerous pre-clinical and clinical studies, including a recent cardiovascular clinical outcomes study comprised of 6,144 subjects followed for up to three years. In that study, AGI-1067 achieved significant results in important pre-specified diabetes endpoints, demonstrating an improvement in glycemic control in patients with diabetes already being managed by conventional therapies. In addition, the number of study subjects who developed diabetes for the first time was reduced by more than 60 percent.
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 compound, AGI-1067, is being studied in a Phase III clinical trial called ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study) as an oral therapy for the treatment of diabetes. In addition, the Company has a development program studying AGI-1096, an oral agent in Phase I that is being developed for the prevention of organ transplant rejection in collaboration with Astellas. 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. Additional information relating to the safety, efficacy or tolerability of AGI-1067, may be discovered upon further analysis of trial data. The 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. There may be significant costs incurred by AtheroGenics as a result of AstraZeneca's decision to terminate the AGI-1067 collaboration and license agreement. 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, 2006 and Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
Mark P. Colonnese
Executive Vice President
Schwartz Communications, Inc.
Stern Investor Relations, Inc.