Canadians Hope $250 Mln Trial Can Revive Failed Heart Drug Dalcetrapib

By Ben Hirschler

June 10, 2015

(Reuters) - A Canadian team hopes to revive a heart drug ditched by Roche three years ago by running a major clinical trial targeting only those patients with the right genetic profile to benefit from its ability to boost HDL cholesterol.

The Swiss drugmaker, which has licensed rights to dalcetrapib to Quebec-based DalCor Pharmaceuticals, said on Tuesday it would provide a companion diagnostic for use in the Phase III study.

DalCor estimates about $250 million will be needed for the project, which will be run in collaboration with the Montreal Heart Institute (MHI) and will screen more than 30,000 patients in 30 countries to find 5,000 with the right genetic profile.

Roche scrapped development of dalcetrapib in 2012 due to a lack of meaningful efficacy in an earlier clinical study.

The failure was a blow to Roche and also undermined confidence in the idea of using such drugs to block a protein known as CETP as a way to increase HDL cholesterol levels.

Before the setback, some industry analysts had estimated that dalcetrapib could have achieved up to $10 billion in annual sales.

Such sky-high forecasts now look out of reach but DalCor, backed by Sanderling Ventures, and the MHI believe dalcetrapib could still have a commercial future by cutting cardiovascular deaths in patients with acute coronary syndrome and the appropriate genetic profile.

The project is based on genetic research by researchers at MHI, published in January, indicating that patients with certain genotypes benefited in terms of reduced cardiovascular risk when given dalcetrapib.

CETP inhibitor drugs had at one point been seen as one of the brightest hopes for the pharmaceuticals industry, given the scale of heart disease in the Western world, but the termination of dalcetrapib and other compounds in the class dampened enthusiasm.

Merck's anacetrapib and Eli Lilly's evacetrapib are currently the only such products in final-stage Phase III clinical trials.

Statins have dramatically reduced the number of heart attacks and strokes suffered by the population at large. But heart disease remains the biggest killer in the world, creating an opening for more effective medicines.

Recently attention has turned to a newer class of injectable cholesterol drugs that target a protein known as PCSK9, with Amgen and Sanofi both racing to get their rival products to market.


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