Health and Healthcare

Nivalis Therapeutics Crumbles on Failed Mid-Stage Trial

Chris Lange

Published: November 29, 2016 2:58 pm

Last Updated: January 12, 2020 5:19 pm

Nivalis Therapeutics, Inc. (NASDAQ: NVLS) is watching its shares crumble on Tuesday after the company gave an update on its mid-stage Cystic Fibrosis (CF) trial. Specifically, the company announced topline results from the its Phase 2 trial evaluating the efficacy and safety of two doses of cavosonstat, in adult patients with CF who had two copies of the F508del-CFTR mutation and were being treated with Orkambi.

There were no dose limiting toxicities and cavosonstat was well tolerated at all doses in the trial. The trial failed, however, to demonstrate benefit in absolute change in percent predicted FEV1, the trial’s primary endpoint, or in sweat chloride reduction at 12 weeks.

Although Nivalis’ study did not meet the primary endpoint, these data help inform the overall body of CF research, and the company remains dedicated to completing its current clinical CF research program.

For some background, Nivalis is a clinical-stage pharmaceutical company committed to the discovery, development and commercialization of therapeutics for people with CF. In addition to developing innovative solutions intended to extend and improve the lives of people with CF, Nivalis plans to utilize its proprietary S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to develop therapeutics for other diseases.

Jon Congleton, President and CEO of Nivalis, commented:

While we are disappointed in the outcome of this trial, we plan to continue to investigate the therapeutic potential of cavosonstat and our S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to determine  next steps.

Shares of Nivalis were last trading down nearly 60% at $2.55, with a consensus analyst price target of $23.75 and a 52-week trading range of $2.50 to $9.35.