Blow for Roche as it halts diabetes drug trial
pharmafile | July 10, 2013 | News story | Research and Development, Sales and Marketing | Roche, aleglitazar, diabetes
Roche has stopped a late-stage trial of its investigational diabetes drug aleglitazar over safety concerns.
The move was prompted by the independent Data and Safety Monitoring Board (DSMB), which recommended that the trial be halted due to “safety signals and lack of efficacy”.
The AleCardio Phase III trial was looking at aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes.
Patients in the late-stage trial suffered side effects affecting organs such as their kidneys and hearts, according to the firm.
This is a big blow for Roche as analysts had forecast 2 billion Swiss francs ($2.05 billion) in peak sales from the drug.
Hal Barron, chief medical officer at Roche, said: “The safety of patients is our first priority. Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies.
“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.”
The Swiss firm said in a statement that data from the trial will be further analysed to fully understand the findings and will be made available at a future medical meeting.
The drug was a risky bet by the company, as AstraZeneca scrapped development of a similar class of drug in 2006, the same year as Bristol-Myers Squibb ended development of another after regulatory setbacks.
While focusing primarily on cancer medicines, Roche has attempted to extend into other areas, but has not seen the success associated with its oncology products.
It has already written off one diabetes treatment in taspoglutide in 2011, a GLP-1 analogue that it hoped could rival Novo Nordisk’ big selling Victoza.
In 2012 Roche was also forced to abandon development of dalcetrapib, which was designed to boost rates of ‘good’ cholesterol, and had some analysts estimating peak annual sales of around $10 billion.
Ben Adams
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