Nivalis (NVLS) Cystic Fibrosis Study Misses Primary Endpoint
Zacks Investment Research | Nov 28, 2016 08:57PM ET
Nivalis Therapeutics, Inc.’s (NASDAQ:NVLS) shares plunged almost 53% in after-hours trading on Nov 28 after the company announced disappointing top-line data from a phase II study on its lead candidate, cavosonstat, for the treatment of cystic fibrosis (CF).
The double-blinded, randomized, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg, administered twice daily, in adults with CF who had two copies of the F508del-CFTR mutation and were being treated with Vertex Pharmaceuticals Inc.’s (NASDAQ:VRTX) Orkambi.
Data showed that the study failed to meet the primary endpoint of demonstrating a benefit in the absolute change in percent-predicted FEV1 (lung function) or in sweat chloride reduction at 12 weeks, in comparison to placebo. However, there was no dose-limiting toxicity and cavosonstat was found to be well tolerated across all the doses in the study.
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