R&D In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
AtheroGenics AGI-1067 dose range restricted in Phase III due to liver concerns: The high-dose 300 mg arm of AtheroGenics' Phase III ANDES trial will be discontinued due to liver toxicity concerns, the company announces Nov. 9. Additional analysis of an earlier Phase III study, ARISE, found rare adverse effects on the liver with a 300 mg dose of the oral anti-inflammatory antioxidant AGI-1067. ANDES was designed to elucidate subgroup effects seen in diabetic patients enrolled in ARISE, a pivotal atherosclerosis trial that failed to meet its primary cardiovascular event endpoint. AtheroGenics and then-partner AstraZeneca had hoped ARISE would support multiple claims for AGI-1067 in subgroups. After the stumble with ARISE, AtheroGenics shifted its focus for AGI-1067 from atherosclerosis to glycemic control in type 2 diabetes. ANDES started enrolling diabetes patients in August as a dose-ranging trial to confirm the ARISE diabetes findings. The trial will continue with the two lower-dose arms (75 and 150 mg); an interim analysis is planned for the second quarter of 2008...
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