AstraZeneca will discontinue the development of its Phase III dual peroxisome proliferator-activator receptor agonist Galida (tesaglitazar) due to safety concerns associated with the class, the company said.

AstraZeneca said that elevation in serum creatinine levels and a subsequent decrease in Glomerular Filtration Rate levels were key to its decision to drop the type 2 diabetes treatment.

The elevation in serum creatinine levels "reversed towards baseline upon stopping treatment with the drug," AstraZeneca said May 4. The firm added that the elevation has "not been associated with kidney toxicity."

There are currently 2,245 patients taking Galida in clinical trials. After evaluating results from the first four Phase III trials and an earlier Phase II trial, the company determined that "the overall benefit/risk profile is unlikely to offer patients significant advantage over currently available therapy."

The firm adds that all primary efficacy endpoints were met in Phase III trials. AstraZeneca said that it would continue to analyze the data from the Galida development program and would "make the data available as appropriate."

The Galida discontinuation may also have implications on AstraZeneca's other PPAR agonist programs currently in development.

AstraZeneca's move comes after Roche pulled the plug on its PPAR gamma candidate R483 on April 26.

Bristol-Myers Squibb ended its partnership with Merck regarding its PPAR Pargluva (muraglitazar)in December. The companies cited the need for additional clinical trials as the reason for the dissolution, which returned the Pargluva rights to Bristol (¹ Also see "Bristol, Merck End Pargluva Collaboration" - Pink Sheet, 22 December, 2005.).

Bristol said it is currently weighing its options concerning development of Pargluva.

Several other dual PPARs, including Dr. Reddy's/Novo Nordisk's ragaglitazar and Merck/Kyorin's MK-0767, have also been discontinued over safety concerns.

-Jonathan Block

AstraZeneca Discontinues PPAR Candidate Galida

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