Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) Shares Slide After VX-661 Data Print
By Josh Gee   
Monday, 23 March 2015 13:53

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX)’s shares fell 5.81 (-4.44%) to $125.19 after the company reported data of a 12-week Phase 2 study studying VX-661. Vertex Pharmaceuticals Incorporated(NASDAQ:VRTX) has come out with data of a 12-week Phase 2 study studying VX-661 combined with ivacaftor in 39 people with CF ages 18 and older having two copies of F508del mutation.

This study ascertained results of two doses of VX-661 combined with ivacaftor. The first and foremost ending of the study was safety.

It also demonstrated the combined regimen was well received and patients were able complete treatment of a period of 12 weeks.

Pulmonary exacerbation was a common adverse event occurring in 38 percent of patients receiving VX-661 and about 44 percent who received placebo as well as cough occurring in 33 percent of patients receiving VX-661 and 39 percent of those who received placebo.

Other endpoint ascertained impact of the combination on the functioning of lungs as well as the mean within-group absolute improvement from baseline in those receiving 100 mg of VX-661 combined with ivacaftor.

The effectiveness and safety data along with other information from the previously completed Phase 2 studies of VX-661 corroborate Vertex’s ongoing Phase 3 program of VX-661 in combination with ivacaftor.

On the other hand, the Phase 3 program tries to ascertain VX-661 combined with ivacaftor and comprises of four Phase 3 studies which also has a study in people having two copies of the F508del mutation. Other three studies would be enrolling people with CF having a single copy of the F508del mutation as well as second mutation which is either residual function mutation, gating mutation or a mutation resulting in minimal CFTR function.

Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex, stated that the efficacy and safety data from the study are similar to prior Phase 2 studies of VX-661 combined with ivacaftor along with providing further support for ongoing Phase 3 program in those having two or one copies of the F508del mutation.

Cystic fibrosis is due to defective or missing CFTR protein which happens from mutations in the CFTR gene. Ivacaftor ensures that cell surface CFTR protein channels open more to increase in the flow of water and salt.




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