Ception Therapeutics, Inc, a privately held biopharmaceutical company, and Cephalon, Inc announced results from a phase-IIb/III clinical trial for Cinquil (reslizumab) as a treatment for paediatric 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 analyse 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 paediatric 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.
Cinquil (reslizumab) is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology.
Ception Therapeutics is a privately held biopharmaceutical company focused on the discovery and development of novel products to address areas of unmet medical need.