Roche announced it will start phase-III clinical investigations for aleglitazar, its innovative PPAR co-agonist R1439 which is uniquely designed to reduce cardiovascular morbidity and mortality in high risk patients with type-2 diabetes. This decision is supported by data from the phase-II Synchrony study published in The Lancet and announced at the American Diabetes Association (ADA) in New Orleans, US. The phase-III programme is anticipated to start in the second half of 2009.

Synchrony, a placebo-controlled dose ranging study in type-2 diabetes patients, showed that aleglitazar had a balanced synergistic effect on both lipid and glucose control with a good safety and tolerability profile in patients with type-2 diabetes.

Cardiovascular disease is currently the leading cause of death amongst those with type-2 diabetes, accounting for half of all deaths. Despite guidelines recommending that cardiovascular risk in this patient group should be reduced by controlling factors such as dyslipidemia, blood pressure, body weight and hyperglycaemia, the majority of patients still do not achieve their treatment goals leaving them vulnerable to both initial and residual cardiovascular events. Significantly, one in ten people experiencing an Acute Coronary Syndrome (ACS) dies within a year.

"Roche is confident that aleglitazar has the potential to reduce cardiovascular morbidity and mortality in this high-risk patient group and is therefore committed to pursuing its rapid development." said Jean-Jacques Garaud, global head of Development Pharmaceuticals Division of Roche.

The focused phase-III outcomes trial will investigate whether once daily 150µg aleglitazar reduces the incidence of cardiovascular mortality, non-fatal myocardial infarction and stroke in patients with type-2 diabetes. The approach in this selected high-risk patient population will be unique as no drug has been demonstrated to reduce cardiovascular risk in type-2 diabetes patients following an ACS event.

Professor Robert Henry, Synchrony clinical investigator and chief VA Endocrinology & Metabolism and Professor of Medicine in Residence at the University of California at San Diego, US commented, "The favourable balance in the safety and efficacy profile of aleglitazar seen in the Synchrony study represents encouraging short-term clinical data for this agent and provides good evidence to enter phase-III investigation."

With the decision to move into phase-III, aleglitazar is Roche's third phase-III clinical trial programme in the area of metabolism. The new phase-III study is a cardiovascular outcomes trial designed to assess the potential of once daily 150µg aleglitazar to reduce cardiovascular mortality, non-fatal myocardial infarction and stroke in type-2 diabetes patients with a recent Acute Coronary Syndrome.

Synchrony was a multicentre, randomised, double-blind, placebo-controlled dose ranging study amongst 332 type-2 diabetes patients (either drug-naïve or pre-treated with 2 oral agents).

Aleglitazar is an innovative investigational treatment designed to reduce the incidence and impact of cardiovascular mortality, non-fatal myocardial infarction and stroke in patients with a recent Acute Coronary Syndrome and type-2 diabetes.