Cystic fibrosis therapeutics firm Nivalis Therapeutics is axing 25 of its 30-strong workforce in a bid to save funds after it was announced late last year that lead candidate cavosonstat (N91115) failed to meet its primary endpoint in a Phase II study. Jon Congleton, president and CEO, and David Rodman, M.D., CMO and evp for discovery, will be among those stepping down. The job cuts, announced yesterday, will cost Nivalis about $3 million in severance pay and leave the company with an estimated $45 to $47 million in net cash for potential strategic alternatives.
The firm had announced in early January that it was exploring and reviewing a range of strategic alternatives. At that time it also confirmed that a second, ongoing Phase II cavosonstat study, SNO-7, would continue, The trial is evaluating the cystic fibrosis transmembrane conductance regulator (CFTR) stabilizer in CF patients taking Kalydeco™ (ivacaftor) and is expected to complete during the first quarter of 2017.
Founded in 2007, Boulder, CO-based Nivalis changed its name from N30 Pharmaceuticals in February 2015. The firm’s portfolio includes multiple small-molecule inhibitors of S-nitrosoglutathione reductase (GSNOR). Nivalis reported on the failed Phase II cavosonstat trial in November 2016. The study was evaluating the drug in adult CF patients with the F508del-CFTR mutation, who were also being treated with Orkambi™. The study failed to demonstrate any benefit in absolute percentage change in predicted forced expiratory volume in the first second (FEV1) values or in sweat chloride reduction at 12 weeks.