ColonaryConcepts Announces Commencement Of Phase IIb Trial Of Novel Colonoscopy Preparation Kit
Published: Oct 12, 2017
GI-Expert Developed Prep Kit Designed to Improve Patient Experience Progresses in Development
BOSTON--(BUSINESS WIRE)--ColonaryConcepts, LLC today announced that its partner, Sebela Pharmaceuticals, plans to initiate a Phase 2b clinical trial with its proprietary colonoscopy preparation kit, EC Prep. EC Prep is comprised of nutritionally balanced and palatable bars and beverages incorporating the standard purgative active ingredient, PEG 3350, as well as electrolytes. The product’s aim is to improve patient experience and compliance in preparing for a colonoscopy, which many experts call the gold standard procedure to screen for colorectal cancer, the second-leading cause of cancer-related deaths in the United States. The Phase 2b trial is expected to commence this quarter.
Sebela Pharmaceuticals, a specialty pharmaceutical company with a gastrointestinal focus, which acquired worldwide rights to ColonaryConcepts' unique colonoscopy preparation product earlier this year, is responsible for developing and commercializing EC Prep.
“We are pleased that Sebela is accelerating with the clinical development of EC Prep,” said Herbert Stern, Chief Executive Officer of ColonaryConcepts. “We are confident that this study will reinforce the successful results from our Phase 2a trial, which showed successful colon cleansing: over 90% of patients using the lead formulation had ‘excellent’ or ‘good’ rated colonoscopies. Patients also reported a high rate of satisfaction, particularly compared with previous preps, and no serious adverse events were observed.”
The 2b trial of EC Prep will likewise assess the efficacy and safety of the bowel prep compared to a widely used competitive product. Following the completion of this study, Phase 3 trials are expected to begin during the first half of 2018, with a potential New Drug Application submission in 2019.
“A more patient-friendly preparation for colonoscopies could lead to increased compliance, thus more patients screened overall, and fewer last-minute cancellations from patients who have been unable to complete other colon preps,” said Dr. Douglas K. Rex, a lead clinical trial investigator and Professor of Medicine and Director of Endoscopy, Indiana University School of Medicine. “The opportunity to improve the colonoscopy experience, which already puts stress on some patients, with a safe, effective and more appealing preparation will be important to continue maximizing detection of potentially cancerous polyps."
A colonoscopy allows for accurate diagnosis and treatment without the need for a major operation. However, non-compliance with prescribed colonoscopy preparation is a major stumbling block to effective diagnosis and treatment. In a colonoscopy, the doctor uses a long, flexible, tubular instrument that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities. About 15 million colonoscopies were conducted in the United States in 2015.
ColonaryConcepts was founded by gastroenterologists who were dissatisfied with available colonoscopy preparations. The company is funded by private investors, over one hundred of whom are also gastroenterologists.
ColonaryConcepts continues to develop its innovative, patient-friendly technology platform, focusing on improving gastrointestinal health. Earlier this year, the Company completed a successful Phase 1 study of C-Bar™, a novel treatment for chronic constipation, and is advancing to a Phase 1b study in early 2018.
About ColonaryConcepts, LLC
ColonaryConcepts, LLC, headquartered in Newton, MA, is a privately held company committed to developing patient-centric innovations that improve gastrointestinal health. The company is developing C-Bar™, a novel treatment for chronic constipation, and other innovative applications of its technology platform. ColonaryConcepts’ physician-led product development team includes Board-certified gastroenterologists, food scientists, pharmaceutical development experts, culinary research chefs, and product design strategists. For more information about ColonaryConcepts, LLC, please visit www.colonaryconcepts.com
About Sebela Pharmaceuticals
Sebela Pharmaceuticals is committed to improving patients’ lives by developing, marketing and selling differentiated, branded prescription pharmaceuticals. The Company’s development and commercial activities are focused in the United States for niche therapeutic markets including gastroenterology and dermatology. For more information about Sebela Pharmaceuticals, please visit www.sebelapharma.com