Vertex (VRTX) To Stop VX-661-Ivacaftor Study, Stock Down

Vertex Pharmaceuticals Incorporated’s (NASDAQ:VRTX) shares were down in pre-market trading on news that the company will be stopping one of the phase III studies being conducted on a VX-661 - ivacaftor (trade name: Kalydeco) combination.

The company announced that it will not be continuing the phase III study in patients with one copy of the F508del mutation and a second mutation that results in minimal CFTR function. The decision was based on a planned interim futility analysis of the first part (Part A) of the two-part study. The analysis by an independent Data Safety Monitoring Board (DSMB) showed that VX-661 plus ivacaftor did not result in a pre-specified improvement in lung function. The DSMB recommended that the study should be stopped and enrolment should not be initiated in Part B of the study.

Vertex said that the results indicate that a triple combination regimen may provide more benefit to this particular patient population and expects to initiate a study of a next-generation corrector with VX-661 and ivacaftor in this group of patients. The study is likely to commence later this year once phase I data on healthy volunteers is available.

We note that the VX-661-ivacaftor combination is currently being evaluated in three other late-stage studies: one in CF patients who have two copies of the F508del mutation (data expected in the first half of 2017), the second in people with residual function mutations (data expected in the first half of 2017), and the third in people with gating mutations that have been shown to be responsive to ivacaftor alone (enrolment scheduled to complete later this year or early next year).

While the discontinuation of the late-stage study comes as a disappointment, expectations were anyway low for the double combination. Importantly, no safety concerns were observed. Depending on data from the phase III program, Vertex plans to seek FDA approval for the VX-661 – ivacaftor combination in the second half of 2017.

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Vertex is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include companies like Geron Corporation (NASDAQ:GERN) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Anika Therapeutics Inc. (NASDAQ:ANIK) – all three are Zacks Rank #1 (Strong Buy) stocks.

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