September 3, 2014
ISIS Heart Drugs Get Good News Drugmaker’s News Encouraging
Written By Bradley J. Fikes
Strengthening the outlook for its drug development pipeline, Isis Pharmaceuticals has announced progress with two of its flagship cardiovascular drugs.
On Tuesday, the Carlsbad biotech presented evidence that an already-approved drug, Kynamro, dramatically reduces risk of heart attacks. And on Friday, it announced another heart medication, ISIS-APOCIIIRx, has begun Phase 3 trials. Both drugs employ Isis’ gene-blocking antisense technology, that stops diseases at the genetic level.
Kynamro, licensed to Isis marketing partner Genzyme, was found to reduce major heart problems and strokes fivefold in a retrospective analysis of the drug, which reduces high levels of LDL, or “bad†cholesterol and triglycerides.
The 104 patients studied take Kynamro to treat heterozygous and homozygous familial hypercholesterolemia, diseases which cause extremely high blood cholesterol levels. The genetic diseases greatly increase the risk of heart attacks and related problems. Patients in the two years before Kynamro treatments experienced “major adverse cardiovascular events,†at a rate of 25.72 per 1,000 months. For patients treated with Kynamro for one year, the rate dropped to 4.85 per 1,000 months.
ISIS-APOCIIIRx is being tested in patients with familial chylomicronemia syndrome, or FCS. This rare genetic disease, which causes extremely high triglyceride levels, greatly increases the risk of cardiovascular disease. FCS affects an estimated 3,000 to 5,000 patients worldwide. The Phase 3 study is a randomized, double-blind, placebo-controlled, six-month study in approximately 50 patients with FCS.
Kynamro helps validate Isis’ approach, said John McCamant, editor of the Berkeley-based Medical Technology Stock Letter. The drug addresses a limited market and is not a big seller, he said. Kynamro is now owned by French drug giant Sanofi-Aventis. However, the study provides even more evidence in favor of the drug.
“The key value for Kynamro is proof of principle,†McCamant said. “It’s safe, it works by antisense, and Sanofi is still moving forward with it,†McCamant said. “It’s showing a long-term benefit.â€
Critics of Kynamro have said that it might cause liver problems. McCamant said the latest results show that fear was overstated, along with more evidence that Kynamro drastically lowers the risk of adverse events.
McCamant said Kynamro isn’t considered in his rating of the company, which the stock letter recommends buying for under $55. Isis shares closed Tuesday at $40.73, down 3 cents for the day.