Armed with genetic data, UK biotech revisits abandoned Roche cholesterol drug
- London-based biotech DalCor Pharmaceuticals has raised $150 million to investigate a failed Roche cholesterol drug in a new 5,000-person trial, looking at a sub-set of patients with a specific genetic profile.
- The drug, dalcetrapib, was abandoned in 2012 when a large phase 3 trial showed no cardiovascular (CV) benefit. Dalcetrapib is part of a class of drugs known as CETP inhibitors which have consistently fallen short of once lofty expectations.
- Now, DalCor plans to target a subgroup of patients with a specific genetic profile, after researchers analyzing data from Roche’s old study found a near 40% reduction in CV events among patients with the genetic variation.
In the early 2000's, CETP (cholesteryl ester transfer protein) inhibition came into vogue as a way to improve CV disease outcomes by increasing HDL, or “good” cholesterol, levels.
Despite CETP inhibitors’ promise as a method of treatment, a number of big pharma companies tried and failed to demonstrate CV benefit. Just last fall, Eli Lilly halted a 12,000-patient phase 3 study for its CETP inhibitor evacetrapib, citing low probability that the primary endpoint would be reached. Detailed data released earlier this month showed the drug had no clinical benefit even though it raised “good” cholesterol and lowered “bad” cholesterol.
In 2006, Pfizer dropped torcetrapib after it was found to increase risk of death. Roche had no better luck when it tried dalcetrapib in 2012.
But DalCor hopes it can resurrect Roche’s drug by zeroing in on a genetically distinct group of patients. Led by Jean-Claude Tardif from the Montreal Heart Institute, researchers identified a statistically significant CV benefit to the drug in about 20% of the patients who took part in Roche’s nearly 16,000-person study. Among those patients, dalcetrapib led to a 39% reduction in CV events.
DalCor raised $50 million in Series A financing late last year and this week closed a $100 million financing round to help fund its plans for a new trial examining dalcetrapib in 5,000 patients with acute coronary syndrome.
CEO and founding investor Robert McNeil hopes this trial will finally realize the “long expected benefit of CETP inhibitors.” Yet the previous failures suggest this could be a tough challenge, even with new genetic data.