Monday, Ception Therapeutics, Inc., a privately held biopharmaceutical company, and Cephalon, Inc. (CEPH) announced results from the Phase IIb/III clinical trial for Cinquil as a treatment for pediatric eosinophilic esophagit or EoE, an allergic inflammatory condition of the esophagus that can cause difficulty in swallowing and heartburn, and in severe cases can lead to food getting stuck in the esophagus.
Analysis of the data from the study indicated that patients treated with Cinquil showed a statistically significant reduction in esophageal eosinophil levels versus placebo. The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms.
Ception and Cephalon noted that in the second co-primary endpoint, patients treated with Cinquil showed an improvement in their clinical symptoms; however, placebo treated patients also experienced large improvement in their symptoms. Therefore, the study did not achieve statistical significance for this endpoint. The company further stated that 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.
Steve Tullman, Chief Executive Officer at Ception Therapeutics said, "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."
Cephalon said it holds an option to acquire Ception, as previously announced.
CEPH is currently being traded at $54.64 down $4.97 or 8.34% on a volume of 5.91 million shares on the Nasdaq.
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