Concert Pharmaceuticals initiates Phase 2 CTP-656 trial

Concert Pharmaceuticals' Phase 2 clinical trial taking place in the United States and involving CTP-656, also known as deuterated ivacaftor, has been initiated.
CTP-656 is a next generation CFTR potentiator that was developed to treat cystic fibrosis.
“We are excited to initiate our Phase 2 trial with CTP-656 in individuals with cystic fibrosis,” Concert Pharmaceuticals President and CEO Roger Tung said. “In contrast to Kalydeco, Phase 1 clinical results from CTP-656 support dosing it once-daily with food, without regard to the fat content of the food, potentially enabling CTP-656 to support improved adherence and provide real world benefits for patients with cystic fibrosis.”
Concert used deuterium chemistry to modify ivacaftor to create CTP-656. Ivacaftor is available commercially as Kalydeco and is currently the cystic fibrosis standard of care for patients who have gating mutations. Expected by the end of next year are topline results for the Phase 2 trial. The trial will be placebo-controlled, randomized, double-blind and involve parallel groups. It will assess the effectiveness and safety of CTP-656 in patients who have cystic fibrosis with gating mutations.