Cortria thinks it has discovered a way to get the heart benefits of niacin drugs without the embarrassing side effect of making patients red in the face. If it’s right, the Boston-based company might have a drug that can be taken alongside statins, the multi-billion dollar cholesterol-lowering drugs taken by millions of people in the U.S. every day.
Cortria has been pretty coy about what it’s up to—it doesn’t even have a website after being financed by Domain Associates and MVM Life Sciences two years ago. Earlier this week, I caught up with newly hired CEO Daniel Grau, the former chief operating officer of CombinatoRx (NASDAQ: [[ticker:CRXX]]).
The company is building itself around intellectual property from the Technical University of Lodz (excuse my transliteration, but it’s pronounced kind of like Luj) in Poland, which was later acquired by Pharmena, a Polish drugmaker. Researchers at the university discovered a substance, produced during metabolism of niacin, able to raise so-called good HDL cholesterol, lower bad LDL cholesterol, and lower triglycerides—all without the side effect of facial flushing, which causes most patients to quit taking the drug to ward off heart disease. “This product profile has been a Holy Grail of the pharmaceutical industry for a long time,” Grau says.
The discovery, made “partly by accident, and partly by design,” according to Grau, led to the creation of a drug candidate called TRIA-662. Cortria spun off from Pharmena, taking the drug with it. (Pharmena co-owns the IP and has a minority shareholder interest in Cortria.) The Boston firm is leading the clinical development of TRIA-662, which is now in the second of three phases of study normally required for approval.
Cortria has its sights on proving its version of niacin is the next thing for cardiovascular disease. Niacin has been around for years, and has proved its ability to extend patients’ lives (something the expensive statins haven’t yet done). But niacin hasn’t ever become a commercial blockbuster because of the facial flushing issue, Grau says.
About half to 80 percent of patients on niacin experience flushing, Grau says. The drugmaker Merck (NYSE: [[ticker:MRK]]) recently has made some headway by getting approval in Europe for a heart drug called Tredaptive that reduces flushing, yet doesn’t eliminate the effect, Grau says. That drug isn’t going to be available anytime soon in the U.S., as the company’s application hit a roadblock with the FDA, which has asked for more study.
Niacin products such as Abbott Laboratories’ slow-release Niaspan currently generate about $1 billion a year in sales as a class, Grau says. Cortria is trying to learn from that experience by appointing Richard King to its board of directors. King is the president of Brisbane, CA-based Tercica (NASDAQ: [[ticker:TRCA]]), and formerly ran commercial operations at Kos Pharmaceuticals—where he oversaw sales and marketing of Niaspan.
The next step for Cortria will be to run a 200-patient, randomized, placebo-controlled study led by Jean-Claude Tardif of the Montreal Heart Institute, Grau says. Data on the drug’s effect should arrive next year. Then we’ll be able to see if Merck and its fellow big drugmakers will be left red-faced.
