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Cystic Fibrosis Drug Combo May Be Less Effective Than Hoped
Date:7/23/2014

tioned that the phase 3 trial data from Vertex has not yet gone through the peer-review process typically required to give physicians confidence in the results.

An earlier, phase 2 trial -- also with positive results for patients -- was published online in the peer-reviewed journal The Lancet Respiratory Medicine in June.

Cystic fibrosis affects an estimated 30,000 people in the United States, according to the Cystic Fibrosis Foundation. It's an inherited disease that disrupts cells in the lungs and the pancreas, causing mucus to become thick and sticky. The mucus builds up, causing breathing and digestion problems.

"Existing medications target only the symptoms of cystic fibrosis but not the cause of the disease," Gentzsch said. "As a result, they may lead to improvement but do not prevent the overall slow progression of lung disease over time. In addition, many current therapies are time-consuming and can be more difficult to use in young children."

A newer drug known by the brand name Kalydeco targets a protein that doesn't work properly in certain people with cystic fibrosis. Researchers have praised the medication, but it only works in an estimated 5 percent of patients who have a specific genetic variation.

The big question is whether Kalydeco and a drug that's in development known as lumacaftor might provide a one-two punch to treat the wide majority of cystic fibrosis patients. If the combo worked, as some short-term studies have suggested, "the hope would be that disease progression would be slowed and that patients would live longer, healthier lives," Gentzsch said.

But the new study raises doubts. The researchers tested the drugs on epithelial cells, which are found in much of the body, and found evidence that Kalydeco actually reverses some of the effects of lumacaftor. "This is consistent with results reported from recent clinical trials that showed meaningful but modest improvements in lung function in patien
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