NEWTON, Mass.--(BUSINESS WIRE)--ColonaryConcepts, LLC today announced the start of an open label Phase 1b clinical trial in patients with chronic idiopathic constipation (CIC). The company’s experimental treatment, designated “C-bar,” is a solid-form edible bar in a range of palatable flavors that delivers PEG-3350, a well-characterized osmotic laxative. The C-bar is designed to offer patients a more convenient, portable, and palatable daily dose of active ingredient, in chewable form.
“As gastroenterologists, we know how uncomfortable and painful CIC can be, and are committed to exploring new, effective forms of treatment that make managing CIC easier,” says Corey Siegel, M.D., a ColonaryConcepts co-founder and Director of the Inflammatory Bowel Disease Center at the Dartmouth-Hitchcock Medical Center (Lebanon, NH) and Associate Professor of Medicine at The Geisel School of Medicine at Dartmouth.
ColonaryConcepts’ Chronic Constipation Study is an open-label, proof-of-concept, Phase 1b study to assess the safety and effectiveness of a daily dose of C-Bar in up to 25 adult male and female subjects with CIC who are currently managing their symptoms with a single daily dose of MiraLAX® (polyethylene glycol). The C-bar technology - integrating the active laxative ingredient within a solid-form, edible bar - was most recently deployed as part of ColonaryConcepts’ most advanced investigational product: the ECP Colon Prep kit, which has just successfully completed a Phase 2 trial.
As part of the study, patients will consume one daily dose of 17 grams of PEG-3350 in a single C-bar each day for two weeks, and record their experience managing their symptoms. The trial is being conducted at the Investigative Clinical Research site in Annapolis, Maryland, under the direction of Principal Investigator Michael Epstein, M.D. Key endpoints for this study are effectiveness, patient tolerability and safety. ColonaryConcepts expects to use the results from this study to plan a Phase 2 trial in CIC, expected to begin later in 2016.
“We believe we can simplify the steps required for patients to take their prescription, make it far more palatable, and ultimately, more effective,” comments Joshua Korzenik, M.D., ColonaryConcepts co-founder, faculty member at Harvard Medical School and the Director of Brigham and Women’s Hospital Crohn’s and Colitis Center. “Our deep patient experience tells us that there’s a real demand for a better approach, especially as the incidence of constipation escalates.”
About Chronic Idiopathic Constipation
More than 50 million prescriptions are written annually in the United States alone to treat some form of constipation. Chronic idiopathic constipation (CIC), characterized by infrequent and difficult passage of stool over 12 non-consecutive weeks within a 12-month period, afflicts an estimated 14% - 16% of the adult population globally (and an estimated 35 million U.S. patients annually, according to the American Gastroenterological Association). While several FDA-approved products are currently available for patients suffering from CIC, studies confirm that patient experience is unsatisfying: as many as 50% report ineffective symptom relief.
About ColonaryConcepts, LLC
ColonaryConcepts, LLC is headquartered in Newton, MA, and is committed to developing patient-centric innovations that improve gastrointestinal health. Their 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
MiraLAX® is a registered trademark of Bayer Corporation.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of ColonaryConcepts, LLC to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the company will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's clinical programs or provide market approval of the company's products, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.