AtheroGenics Nixes Max Dose in Diabetes Study
AtheroGenics (AGIX) has discontinued the highest dose of AGI-1067 in a planned dosing-range study for the diabetes treatment candidate.
The drugmaker, which announced the study change after Friday's market close, came to the decision to stop offering the 300-milligram dose after discussions with the Food and Drug Administration and review of the risk/benefit profile (namely abnormal liver function) in an earlier phase III trial.
Earlier this year the company diverted AGI-1067 from development for heart disease after the drug showed no advantage over placebo in the primary endpoint in its ARISE trial and raised safety concerns with liver toxicity markers. The company also lost collaboration partner AstraZeneca (AZN). Shortly thereafter AtheroGenics announced it would cut its workforce by 67 employees -- about half -- and streamline operations.
Though AGI-1067 was a no-go in heart disease, AtheroGenics said the 300-mg dose achieved significant results in diabetes endpoints and reduced the number of study subjects who developed diabetes for the first time. Based on those findings the company commenced the ANDES phase III trial to determine optimal dosing for glycemic control.But, after discussions with the FDA and a review of rare adverse effects on the liver with the 300-mg dose in the earlier ARISE trial, the company said it would discontinue the high dose. AtheroGenics said it's still continuing enrollment of the ANDES phase III trial with the 75-mg and 150-mg doses, expecting enrollment to be completed before the end of 2007, with the interim analysis planned for the second quarter of 2008. Shares of micro-cap AtheroGenics were down 28 cents, or 20%, at $1.12 in recent trading Monday.
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