By: Shawn Lawrence
Precision Medicine
Treating Acute Coronary Syndrome: This time
it’s personal
Robert McNeil, managing director of Sanderling and CEO of DalCor
Thanks to the promise of precision medicine, a heart drug ditched three years ago by European multinational Roche Holding AG (Roche) is getting a second shot at a Phase 3 trial.
A
s a potential treatment for patients with acute coronary syndrome (ACS), the drug, Dalcetrapib, had in its first go around made it all the way through to Phase 3 before Roche halted its development due to a lack of meaningful efficacy results. Now, a Sanderling Ventures spin-out company in Montréal, DalCor Pharmaceuticals, has licensed the drug from Roche and launched a new Phase 3 trial to prove its viability as a personalized cardiovascular therapy. This will be a first in cardiovascular disease. As part of this new trial, DalCor says it will work with the Montréal Heart Institute and Roche Diagnostics to screen more than 33,000 patients across 30 countries in the hopes of identifying 5,000 patients who stand to benefit from its ability to boost “good” cholesterol because they have the right genetic profile. As Robert McNeil, managing director of Sanderling and CEO of DalCor explains, the big difference is that this time personal8 BIOTECHNOLOGY FOCUS October/November 2015
ization is the name of the game. “It all comes down the underlying principle behind precision medicine, a patients’ different genetic profile impacts how useful or harmful a drug is to the system,” he says, elaborating that not all drugs are one size fits all. In the case of Dalcetrapib, two Montréal Heart Institute (MHI) researchers Drs. JeanClaude Tardif and Marie-Pierre Dubé, have shown that patients with a certain genotype on a specific gene called ADCY9 (adenylate cyclase 9 on chromosome 16) exhibited reduced cardiovascular risk when treated with dalcetrapib as compared to placebo. It was the pharmacogenomics data presented in this study that convinced McNeil that Dr. Tardif’s findings were groundbreaking. He remembers vividly his excitement when he heard about these findings from Dr. Tardif first-hand. “A mutual friend called me up one day and said, “I’d like you to come and listen to a story
of a colleague of mine that you might find interesting, about a possible drug.” So about a week later I was in his office with Dr. Tardif and basically, he showed me the results of Dalcetrapib in the original Roche Phase 3 trial, which I was aware of and he said, “But if you take what we discovered and look at a particular genotype, there is quite a different outcome.”” “Basically, there is a distinct difference in how Dalcetrapib performs in a group of people with a certain genetic composition,” says McNeil, citing that in Tardif and Dubé’s study, this patient group had a 39 per cent decrease in combined clinical outcomes of heart attacks, strokes, unstable angina, coronary revascularizations and cardiovascular deaths when taking the drug. “First a 39 per cent decrease in hard outcomes on top of statins is a very big improvement, and second, it was the first time in cardiovascular disease that we had evidence that a drug could impact those who have a certain
