Roche has terminated development of aleglitazar due to safety concerns about the late-stage diabetes treatment.
The Swiss major said that following the results of a regular review of a Phase III trial of aleglitazar, an independent data and safety monitoring board has recommended to halt the study "due to safety signals and lack of efficacy". Based on the recommendation, Roche has decided to terminate that trial and all other studies involving aleglitazar.
The drug is a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist, similar to the thiazolidinediones such as GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone). It was being evaluated in patients with a recent acute coronary syndrome event and type 2 diabetes but the review highlighted concerns about fractures, heart failure and gastrointestinal bleeding.
Hal Barron, Roche's chief medical officer, said that "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".
It looks like the end of the road for dual PPAR alpha/gamma agonists. Seven years ago, development of both Bristol-Myers Squibb and Merck & Co's Pargluva (muraglitazar) and AstraZeneca's Galida (tesaglitazar) was ended over safety concerns.