AstraZeneca has discontinued development of Galida (tesaglitazar), a dual PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist that was in Phase III development for the treatment of the glucose and lipid abnormalities associated with type 2 diabetes.
The decision follows results from four Phase III clinical trials (GALLANT 6,7,8 and 9) and one Phase II trial (ARMOR), which showed greater than anticipated elevations in serum creatinine levels and an associated decrease in Glomerular Filtration Rate (GFR). Although the rising levels reversed towards baseline upon stopping treatment with the drug and have not been associated with kidney toxicity, AstraZeneca considered the overall benefit/risk profile of Galida would be "unlikely to offer patients significant advantage over currently available therapy" and thus terminated development.
"We have acknowledged that GALIDA was in a class with a high degree of uncertainty and the decision to discontinue is disappointing," said David Brennan, AstraZeneca ceo. "We remain committed to further strengthening AstraZeneca's pipeline of new medicines both from our own research efforts and through the continued pursuit of external opportunities to enhance our business."
At the time of the decision there were 2,245 patients taking Galida within clinical trials. All trials will now be brought to a close and physicians will be advised to switch patients to the alternative available therapies.
AstraZeneca will make further Galida data available through scientific presentation, publication and its clinical trials website once analysis has been completed.