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Nivalis Starts Dosing in Second Phase II Cystic Fibrosis Study

Nivalis Therapeutics, Inc. NVLS announced that it has dosed the first patient in a second phase II study on its lead candidate, N91115, being evaluated for the treatment of cystic fibrosis (CF).

The 12-week, double-blind, randomized, placebo-controlled, parallel group, proof-of-concept study is being conducted to evaluate the effect of N91115 (400 mg) as add-on therapy to Vertex Pharmaceuticals Incorporated’s (VRTX) Kalydeco in adults with CF, who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein. Data from the study is expected in the first half of 2017.

proof-of-conceptstudy is being conducted to evaluate the effect of N91115 (400 mg) as add-on therapy to Vertex Pharmaceuticals Incorporated’s VRTX Kalydeco in adults with CF, who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein. Data from the study is expected in the first half of 2017

Early last month, Nivalis announced achieving a 50% enrollment milestone in a phase II study on N91115. The study is in progress to evaluate the efficacy and safety of two doses of N91115 (200 mg and 400 mg) in adults with CF who have two copies of the F508del-CFTR mutation and are being treated with Vertex’s Orkambi. The company expects to report data from this study in the fourth quarter of 2016.

We are encouraged by the company’s progress with N91115. According to the Cystic Fibrosis Foundation, CF affects an estimated 70,000 people across the world, mainly in the U.S. and Europe.

We note that the FDA granted Fast Track and orphan drug status to N91115 earlier this year for the treatment of patients with CF.

Nivalis carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Retrophin, Inc. RTRX and ANI Pharmaceuticals, Inc. ANIP, each sporting a Zacks Rank #1 (Strong Buy).

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