Anglo-Swedish drugmaker AstraZeneca has dropped the development programme for its late-stage diabetes agent, the dual PPAR alpha and gamma agonist Galida (tesaglitazar).
According to the group, the decision was made after an analysis of data from the first four of eight Phase III clinical trials (GALLANT 6,7,8 and 9) and one Phase II study (ARMOR) indicated that the drug’s overall benefit/risk profile is unlikely to offer an advantage over currently-marketed treatments, and not because of any safety issues.
Several promising candidates in the dual PPAR agonist class, which tackle both insulin resistance and high blood lipids in type 2 diabetes, have already fallen by the wayside because of toxicity, with side effects such as oedema, raised levels of hepatic enzymes and tumours in rodents. Casualties include Takeda's TAK-559, Novo Nordisk/Dr Reddy's Laboratories' ragaglitazar, Japan Tobacco's reglitazar and Merck & Co's MK-767.
And, more recently, Bristol-Myers Squibb said it may have to abandon efforts to develop its new PPAR diabetes drug Pargluva (muraglitazar), after the US Food and Drug Administration requested more data on side effects late last year.