After evaluating data from analysis recently obtained results from the first four of eight phase III clinical trials and one phase II trial, the company decided that the overall benefit / risk profile is unlikely to offer patients significant advantage over currently available therapy.
Central to the company’s decision was data showing that patients taking the drug had elevated levels in their blood of creatinine – a substance which is associated with kidney damage.
Galida belongs to a class of drugs called PPAR agonists which includes a number of other drugs, including Bristol-Myers Squibb’s own diabetes drug Pargluva, which have been pulled from development due to safety concerns.
“We have acknowledged that Galida was in a class with a high degree of uncertainty and the decision to discontinue is disappointing. 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,” said David Brennan, CEO of AstraZeneca.