Roche Halts Type 2 Diabetes Candidate Trial After Phase III Failure
Roche said today it halted development of aleglitazar—including its AleCardio Phase III trial and other trials involving the diabetes drug candidate—at the recommendation of the trial’s independent data and safety monitoring board, in the latest late-stage clinical failure for its class of drugs and Roche’s Basel-based research effort.
While a Roche announcement stated that the company acted due to “safety signals and lack of efficacy,” several news reports quoted a company spokesman as saying the drug caused side effects in some patients that included fractures, kidney failure, and heart failure.
“We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease,” Hal Barron M.D., Roche’s CMO and head, global product development, said in the statement. “Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies.”
Roche said data from AleCardio will be further analyzed, and its findings will be made available “at a future medical meeting.” The trial was designed to evaluate the efficacy and safety of aleglitazar in more than 7,000 patients with a recent acute coronary syndrome event and type 2 diabetes.
Aleglitazar’s failure is the latest for the dual PPAR agonist class, a category that includes GlaxoSmithKline’s Avandia—as well as several failed candidates, including two whose development was halted in 2006 by AstraZeneca (tesaglitazar) and Bristol-Myers Squibb (muraglitazar). Concerns over heart problems linked to Avandia in 2010 prompted FDA to restrict use of the drug—while the European Commission suspended sales of the drug on the continent and placed Avandia on its “Community List of Not Active Medicinal Products for Human Use.”
The scuttling of aleglitazar development marks the latest setback for Roche’s Basel research operations or pRED, which since the company’s 2009 merger with Genentech has lagged behind the Genentech Research and Early Development or gRED when it comes to bringing new drugs to market.
Last year, for example, Roche halted Phase III clinical trials of the pRED-developed experimental heart drug dalcetrapib—a failure that some said may have been behind Roche’s subsequent decision to shut down its Nutley, NJ, research site (focused on early-stage research on drugs for cancer and inflammatory and viral diseases) and eliminate its 1,000 jobs. In January, Roche named a new head for pRED, John C. Reed, M.D., Ph.D., previously CEO of the Sanford-Burnham Medical Research Institute.