Celgene’s Otezla misses endpoint in Ph III ankylosing spondylitis study

Shares of US biotech firm Celgene (Nasdaq: CELG) fell 3.5% in premarket trade, but were up 1.2% $86.75 by mid-morning after the company said results from a late-stage trial of Otezla (apremilast) failed to meet its primary endpoint.

Celgene announced results of its Phase III POSTURE study evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis. The Otezla arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16. However, in a pre-specified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing.

DSM recommends study continues