Ception initiates Ph II/III trial of EE drug

USA-based Ception Therapeutics has initiated a multicenter, Phase II/III trial to evaluate reslizumab, a humanized monoclonal antibody against interleukin-5 for the treatment of eosinophilic esophagitis pediatric patients. The Food and Drug Administration has granted orphan drug status to reslizumab for this indication.

The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between five and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the evaluation are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The study is being conducted at multiple centers and will enroll approximately 172 patients.