FDA Also Grants Orphan Drug Status to Reslizumab for Pediatric EE
MALVERN, Pa., March 5 /PRNewswire/ -- Ception Therapeutics, Inc. announced today the initiation of a multi-center, Phase II/III clinical trial to evaluate reslizumab, a humanized monoclonal antibody (mAb) against interleukin-5 (IL-5), for the treatment of eosinophilic esophagitis (EE) in pediatric patients. EE is a chronic inflammatory disease characterized by difficulty swallowing, vomiting, stomach or chest pain, and a failure to thrive. IL-5 is the major cytokine responsible for the eosinophilic inflammation of the esophagus seen in this condition.
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to reslizumab for the treatment of pediatric EE. This designation is part of a well-established program designed to support the development of drugs for rare diseases which affect fewer than 200,000 people in the United States. Depending upon the study results, Ception expects to file a Biological License Application (BLA) with the FDA for reslizumab based on this study.
"The initiation of this study marks a major corporate milestone for Ception," said Steve Tullman, co-founder, President and CEO of Ception Therapeutics, Inc. "Over the last decade, awareness of EE has dramatically increased, but currently, there is no approved treatment. Children with this disease may suffer significant morbidity and it can be a challenge for them to maintain proper nutrition."
The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between 5 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 study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple centers and will enroll approximately 172 patients. For more information on this clinical trial, please visit http://www.clinicaltrials.gov [Identifier: NCT00538434].
Reslizumab is a humanized mAb against IL-5. IL-5 plays a crucial role in the maturation, growth and chemotaxis of eosinophils, inflammatory cells implicated in a number of allergic diseases.
About Eosinophilic Esophagitis
Eosinophilic esophagitis (EE) is a disease that has become increasingly recognized in children and adults over the last decade.(1) It is characterized by an accumulation of eosinophils in the esophagus in association with symptoms that frequently mimic gastro-esophageal reflux disease (GERD).(2) Specifically, patients typically report symptoms that include difficulty feeding and failure to thrive in younger children, as well as vomiting, epigastric or chest pain, dysphagia, and food impaction.(2) The diagnosis must be made on the basis of an esophageal biopsy demonstrating the presence of significant numbers of eosinophils, clinical symptoms, and the absence of acid reflux or failure to respond to acid reduction therapy.(1)
Allergic responses have been strongly implicated in the etiology of EE.(1) The overexpression of the cytokine IL-5 by T helper type 2 cells is thought to play a major role in the pathogenesis of the disease.(1) Therapies currently utilized for EE include severely restricted diets, including an elemental formula diet typically administered by nasogastric or gastrostomy tube.(2) There are no approved pharmacologic therapies for EE, although corticosteroids are sometimes administered to patients.
About Ception Therapeutics, Inc.
Ception Therapeutics is a biopharmaceutical company focused on the
discovery and development of novel products to address areas of unmet
medical need. The Company's pipeline includes reslizumab in clinical
development for eosinophilic inflammatory conditions and an orally
available small molecule anti-TNF program. Ception Therapeutics pursues new
drug targets through a proprietary thermodynamics-based rational drug
design platform. For further information, visit http://www.ceptiontx.com.
(1) Furuta, G., Liacouras, C., et al. Eosinophilic Esophagitis in
Children and Adults: A Systemic Review and Consensus Recommendations
for Diagnosis and Treatment. Gastroentergology 2007:133:1342-1363
(2) Blanchard, C., Wang, N., Rothenberg, M. Eosinophilic esophagitis:
Pathogenesis, genetics, and therapy. J. Allergy Clin Immun. November
2006 (Vol. 118, Issue 5, Pages 1054-1059)
|SOURCE Ception Therapeutics, Inc.|
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