PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Detailed results from a Phase 2B study of the lead formulation of a novel colonoscopy prep (ECP) being developed by ColonaryConcepts, LLC show the investigational treatment to be as effective and safe as MoviPrep Split-Dose, a standard, FDA-approved colonoscopy prep. At the same time, the ColonaryConcepts prep offered a higher level of patient satisfaction and preference than the standard prep. The investigational prep is designed to be good-tasting and easy-to-consume, with no fasting and lower fluid requirements than standard preps. ECP is a kit comprising flavored edible bars and low-volume beverages incorporating the standard purgative active ingredient, PEG 3350, and key electrolytes, which a patient consumes during the 24 hours prior to colonoscopy.
Results from the randomized, colonoscopist- and investigator-blinded study were announced by principal investigator and world-authority on colonoscopy, Douglas K. Rex, M.D., Distinguished Professor of Medicine, Indiana University School of Medicine.
“The results with ECP in this study closely track with the results of an earlier Phase 2A study which I presented at the American College of Gastroenterology Conference in 2016, supporting a positive safety and efficacy profile as well as patient preference for ECP,” said Dr. Rex. “Additionally, this study has identified the Harefield colonoscopy rating scale, which enables detailed colon segment-by-segment analysis, as a more accurate and precise scoring methodology than other endoscopic visibility scales when using central colonoscopy readers.”
The study tested ECP randomized against a U.S. Food and Drug Administration-approved active comparator, MoviPrep Split Dose. The primary outcome was the proportion of subjects with an endoscopic visibility rating of excellent or good based on a modified 4-point Aronchick scale, as adjudicated by central reader. Secondary endpoints included rating by additional accepted endoscopic visibility scales (Boston Bowel Preparation and Harefield scales), including segment-by-segment endoscopic visibility based on the Harefield scale, as well as safety, and patient tolerability. A total of 63 patients were treated, with 32 randomly assigned ECP and 31 assigned to MoviPrep. All colonoscopies were successfully completed, and there were no observed safety issues or electrolyte shifts. The ECP formulation achieved 93.8% efficacy, outpacing the comparator prep (89.3% efficacy), and patients showed good tolerance and preference for ECP over the comparator.
Corey A. Siegel, M.D., M.S., a co-founder of ColonaryConcepts, and Director of the Inflammatory Bowel Disease Center at the Dartmouth-Hitchcock Medical Center and Associate Professor of Medicine at The Geisel School of Medicine at Dartmouth commented, “Approximately 40% of people who ought to have a colonoscopy avoid the procedure, and a top reason cited for their avoidance is the prep. Results from this study show that this innovative investigational product performed better at colon cleansing than MoviPrep, with strong patient satisfaction reported by those who used the lead ECP formulation. We believe the results from this trial, which corroborate our earlier Phase 2A trial, suggest this new approach to colonoscopy prep may have a positive impact on patient willingness to undergo this potentially life-saving colorectal cancer screening procedure.”
Dr. Siegel noted that ColonaryConcepts plans to initiate a Phase 3 clinical study of this lead formulation of ECP in Q1 2021.
Detailed Study Results
- ECP outperformed against MoviPrep in achieving the primary endpoint, efficacy as rated by a central reader using a modified 4-point Aronchick scale
- Investigators recognized significant variation between local and central reader scoring when using the Aronchick scale. Therefore, other validated scales (Harefield, Boston Bowel Prep) were applied.
ECP also outperformed MoviPrep using the two alternative, well-accepted scales:
- using the Harefield scale, ECP scored 93.8% vs 83.8% for MoviPrep.
- using the Boston Bowel Prep scale, ECP scored 87.5% vs 80.6% for MoviPrep.
- ECP also outperformed MoviPrep in analyses of each of the five colon segments, notably within the critical ascending segment (ECP at 96.9% visibility, versus MoviPrep at 90.3% efficacy).
- The Harefield scale, which measures visibility upon withdrawal of the colonoscope, and provides valuable detailed segment by segment analysis, was determined to be the most appropriate scale to use in the upcoming Phase 3 study.
- ECP demonstrated good tolerability and scored higher than MoviPrep in patient satisfaction (the mean overall Hatoum Patient Satisfaction Questionnaire score was 130.5 for ECP versus 112.9 for MoviPrep, a difference of 17.6, with a 95% confidence interval).
“The ECP approach allows patients to eat solid food bars and drink palatable low-volume beverages, a patient-friendly design that participants in the study favored over conventional preps,” comments Joshua Korzenik, M.D., a co-founder of ColonaryConcepts, and Faculty Member at Harvard Medical School and the Director of the Brigham and Women’s Hospital Crohn’s and Colitis Center. “This suggests that more patients will adhere to the colonoscopy testing guidelines we recommend – and the more tested, the better the odds of detecting colorectal cancer. Colonoscopy is still recognized as the gold standard – the best way to catch this cancer at an early stage. By making the preparation for the procedure easier, we believe products like ECP can lower patient resistance to colonoscopies, and thus can help attain these important public health goals.”
About ColonaryConcepts, LLC
ColonaryConcepts, LLC is headquartered in Palm Beach Gardens FL, and is committed to developing patient-centric innovations that improve gastrointestinal health. The company currently has two product candidates in clinical development: ECP, which is expected to enter Phase 3 clinical trials in early 2021, and the “C-bar”, a novel product candidate using PEG-3350 in mini-bar form for chronic constipation, which is currently preparing for a Phase 2 clinical trial. 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