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news.Shares in Georgia-based AtheroGenics dipped over 20% after it announced amendments that will delay the phase III trial of the company's lead compound in heart disease.
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The shares tumble came after the company provided an update on its AGI-1067 clinical program for the treatment of atherosclerosis in patients with coronary artery disease. The drug is currently being tested in a pivotal phase III clinical trial, called ARISE, at leading cardiovascular research centers throughout the US, Canada, the UK and South Africa.
AtheroGenics has submitted to the FDA proposed amendments to the ARISE clinical trial protocol designed to enhance the trial as well as to accelerate the current pace of the trial. Subject to approval by the FDA, AtheroGenics intends to increase patient enrollment in ARISE to a target of 6,000 patients from the current target of 4,000 patients, thus providing an estimated 50% increase to 10,000 patient-years of exposure during the course of the trial.
At the current rate of enrollment, the company estimates that the trial would achieve full patient enrollment by mid-2005. Given the increased size and longer duration of the trial, the company has also proposed to eliminate the minimum 12 month follow-up period for subjects.
In addition, AtheroGenics has proposed a decrease in the target number of clinical events from 1,160 to approximately 1,000. This revised target number will continue to yield greater than 95% statistical power to detect a 20% difference in clinical events between the study arms.
AtheroGenics expects that, with the above changes, the trial should be completed by the end of the first quarter of 2006. The company plans to file a new drug application (NDA) with the FDA as soon as possible after the trial is completed and results are analyzed.
“We believe that these proposed changes will greatly enhance the overall quality of the ARISE Study by increasing the size and power of the safety database” said Dr Rob Scott, senior vice president of clinical development and regulatory affairs and chief medical officer at AtheroGenics. “In addition, the statistical power of the efficacy database of 1,000 events remains superior when compared to other contemporary studies sponsored by the largest pharmaceutical companies.”
AtheroGenics continues to seek a strategic partnership agreement with a major pharmaceutical company to complete the development and commercialization of AGI-1067. The company is currently reviewing with prospective partners the previously announced results of the CART-2 clinical trial and the progress in the ARISE clinical trial.
Additionally, a complete publication of the results of the CART-2 study, including a full analysis of efficacy and safety data, is expected later this year.