Celgene (CELG) said on Wednesday morning that a phase 3 trial of Otezla, the company’s oral inhibitor of phosphodiesterase 4 (PDE4) already approved in active psoriatic arthritis, failed to meet its primary endpoint in active ankylosing spondylitis, a painful inflammatory disease. Otezla did not demonstrate a statistically significant improvement versus placebo on the percentage of patients who achieved an ASAS 20 response (Assessment of Spondylo Arthritis International Society) at week 16.
In a somewhat uncharacteristic move for the larger biotech, Celgene spun results in a early AS patients as positive and plans to begin another phase 3 trial. In a pre-specified analysis, said the company, efficacy was observed at Week 24 in a subset of patients with early-stage disease, and based on the 24-week results, an independent data monitoring committee recommended that the study continue. Celgene will collect magnetic resonance imaging (MRI) data in the subgroup at week 52 and at additional time points. Radiographs will also be taken on all study patients at week 104.
Analysts attribute little value to the ankylosing spondylitis program; CELG dropped 3% in early trading.
One or more of PropThink’s contributors are long CELG.
