BOSTON--(BUSINESS WIRE)--ColonaryConcepts, LLC (CC) today announced positive topline results from a randomized, colonoscopist-blinded Phase 2 clinical study of the company’s novel investigational colonoscopy prep kit. The kit, to be available by prescription, is comprised of nutritionally balanced bars and beverages incorporating the standard purgative active ingredient, PEG 3350, which a patient consumes during the 24 hours prior to colonoscopy. Results of the study, ended after 65 patients completed a colonoscopy, showed successful colon cleansing (i.e., endoscopic visibility) in that over 90% of patients using the lead formulation had ‘excellent’ or ‘good’ rated colonoscopies. At the same time, participants reported high satisfaction with the CC kit and experienced no serious adverse events.
ColonaryConcepts plans to present the detailed clinical results from the study at major medical meetings and in publication later in 2016 and 2017, and is meeting with the Food and Drug Administration (FDA) in August 2016 at an End-of-Phase 2 Meeting to discuss plans to proceed to Phase 3 clinical trials.
“We are very pleased with the results of this study, which provide strong clinical evidence supporting our approach and negate the long-held belief that fasting and the ingestion of high volumes of fluids are required for proper colonoscopy preparation,” said Corey A. Siegel, M.D., M.S., co-founder of ColonaryConcepts, co-inventor of the investigational colon prep kit, Director of the Inflammatory Bowel Disease Center at the Dartmouth-Hitchcock Medical Center (Lebanon, NH) and an Associate Professor of Medicine at The Geisel School of Medicine at Dartmouth. “The results from this study – more than 90% of patients using the lead formulation had ‘excellent’ or ‘good’ rated colonoscopies – clearly encourage us to expand our investigations to a Phase 3 clinical trial, which we plan to initiate in Q4 2016.”
“Patients participating in this clinical study reported high satisfaction,” said Joshua Korzenik, M.D., ColonaryConcepts co-founder, co-inventor of the investigational prep kit, faculty member at Harvard Medical School and the Director of Brigham and Women’s Hospital Crohn’s and Colitis Center. “That’s good news because we are determined to help make it easier for all patients to undergo regular colorectal screening – still recognized as the best way to catch this cancer at an early stage.”
Colonoscopy is the “gold standard” method of screening for colon cancer, according to the National Institutes of Health, and the Centers for Disease Control and Prevention report that 6 of 10 deaths from colon cancer could be prevented by proper screening. While more than 15 million patients in the United States undergo colonoscopy, as many as 45% more go unscreened. Approximately 2/3 of those unscreened individuals cite the current standard colonoscopy prep as the reason they avoid screening. The current standard prep requires fasting and the ingestion of large volumes of poor-tasting, salty, purgative-containing fluids. Of those patients who begin the standard prep, suboptimal preparation occurs in as many as 25% of the cases.
ColonaryConcepts’ colonoscopy prep technology includes physician- and food scientist-formulated kits that are designed specifically to address patients’ major pain points in preparing for a colonoscopy. The core components of the lead formulation – solid bars and flavored beverages containing the active ingredients – may be regulated as drugs by the FDA. CC will seek FDA approval under the statutory 505(b)(2) NDA regulatory pathway.
“ColonaryConcepts was specifically founded to respond to a clear patient-voiced need for a better patient experience in colonoscopy. Our goal is to increase compliance with this life-saving cancer screening procedure,” said Herbert B. Stern, co-founder and Chief Executive Officer of ColonaryConcepts. “While the novel colonoscopy prep kit is our most advanced product, we are also creating a pipeline of other products for gastrointestinal health that use food as a delivery vehicle for active pharmaceutical ingredients and that address the needs of specific patient populations within both the prescription and Over-the-Counter (OTC) drug markets.”
About ColonaryConcepts LLC
ColonaryConcepts designs and develops innovative therapeutic products for gastro-intestinal health based on a patient-centric technology platform that employs food as a delivery vehicle for active pharmaceutical ingredients to improve the patient experience and increase compliance. For more information, please visit our website at http://www.colonaryconcepts.com.