Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

Nov 23 2009

Ception Therapeutics, Inc., a privately held biopharmaceutical company, and Cephalon, Inc. (Nasdaq: CEPH) today announced results from a Phase IIb/III clinical trial for CINQUIL(TM) (reslizumab) as a treatment for pediatric eosinophilic esophagitis (EoE). The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms. Analyses of the data indicated that patients treated with CINQUIL showed a statistically significant reduction in esophageal eosinophil levels versus placebo. In the second co-primary endpoint, patients treated with CINQUIL showed an improvement in their clinical symptoms; however, placebo treated patients also experienced an unexpectedly large improvement in their symptoms. Therefore, the study did not achieve statistical significance for this endpoint. CINQUIL was well tolerated in the study, with an adverse event profile comparable to placebo. Ception and Cephalon continue to fully analyze the data and are planning to perform an analysis of an ongoing open-label extension study to help further assess the clinical results.

"We are pleased to see a positive biological effect of CINQUIL," said Steve Tullman, Chief Executive Officer at Ception Therapeutics. "Conducting clinical studies in a new disease area is always challenging. We will continue to review the data from this study and from our ongoing open-label study to find the best path forward for CINQUIL for the treatment of eosinophilic esophagitis."

The four-month, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of CINQUIL in 226 pediatric patients between five and 18 years of age with poorly controlled EoE. Study participants were randomized to receive one of three dose levels of CINQUIL (1 mg/kg, 2 mg/kg, and 3 mg/kg) or placebo. The reduction of esophageal eosinophils was marked in all active groups, with statistically significant reductions of peak esophageal eosinophils (p<0.0001) at all dose levels compared to placebo. All active groups also experienced improvement in the physician global assessment of their symptoms. However, the placebo cohort also demonstrated improvement in their physician global assessment; therefore, there were no statistically significant differences between the active groups and the placebo group for this endpoint.

As previously announced, Cephalon holds an option to acquire Ception. A Phase II study of CINQUIL in eosinophilic asthma is ongoing. The parties have agreed to extend Cephalon's option exercise period until a specified period of time after delivery of the top-line results for the Phase II eosinophilic asthma study.

SOURCE Cephalon, Inc.; Ception Therapeutics, Inc.