Lilly sets back evacetrapib data deadline

Eli Lilly has extended a trial of its cholesterol drug evacetrapib by six months, which will likely push results out towards the middle rather than beginning of 2016.

The company said the decision was taken on the recommendation of the ACCELERATE trial's executive committee and reflects recent results from other drugs being studied to reduce major adverse cardiovascular events (MACE).

It is understood that Lilly had been waiting for the outcome of a futility test for the trial in the first quarter of this year, which would include an initial assessment of MACE, although it is not clear whether the latest decision relates to that assessment.

Evacetrapib is a drug in the CETP inhibitor class designed to increase levels of high-density lipoprotein (HDL) cholesterol - which according to some studies has a protective cardiovascular effect. 

Most available cholesterol drugs are designed to lower low-density lipoprotein (LDL) cholesterol - considered to be a harmful form that promotes cardiovascular disease, and CETP inhibitors are thought to block the transfer of cholesterol esters from HDL to LDL cholesterol.

Lilly said the extended trial time would make it more likely that ACCELERATE could show whether adding evacetrapib to statin therapy to patients with high-risk atherosclerotic cardiovascular disease (ASCVD).

Discussing the trial last year, David Ricks, president of Lilly's Bio-Medicines division, said: "In lipid management studies, quite a bit of the benefit is often seen in the back half of the trial."

Merck & Co is developing a CETP inhibitor called anacetrapib in a phase III cardiovascular outcomes study (REVEAL), while Bristol-Myers Squibb (BMS) is developing another rival - BMS-795311 - along with China's Simcere Pharmaceutical.

The class has seen its fair share of casualties dropping from the development path however. Roche pulled its CETP inhibitor dalcetrapib in 2012 however after trials revealed no added benefit for the drug when given on top of statin therapy, while several years ago Pfizer discontinued its torcetrapib candidate on safety issues.

Once billed as potential blockbuster drugs, expectations have been scaled back for the CETP inhibitor class particularly as so much attention is now being given to the PCSK9 inhibitor class - led by Sanofi/Regeneron's alirocumab and Amgen's evolocumab - which have generated unprecedented cholesterol-lowering efficacy when added to statins.