Nivalis Therapeutics, Inc. (NVLS), a clinical stage pharmaceutical company focused on treating people with cystic fibrosis, said that the first patient was dosed in the Phase 2 clinical study of its lead investigational drug, N91115.
N91115, a stabilizer of the cystic fibrosis transmembrane conductance regulator or CFTR protein, is being studied for the treatment of CF patients who have two copies of the F508del mutation, when added to Orkambi (lumacaftor/ivacaftor).
"We are pleased to initiate the Phase 2 study as planned to evaluate clinical utility of N91115 in patients with CF, and we expect to report results from the study in the second half of next year," said Jon Congleton, president and chief executive officer of Nivalis.
The 12-week, double-blind, randomized, placebo-controlled, parallel group study is designed to investigate the efficacy and safety of two doses of N91115, 200mg and 400mg, administered twice daily in 135 adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with Orkambi.
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