US-based biotech firm ColonaryConcepts has initiated the Phase Ib Chronic Constipation trial of C-bar, delivering PEG-3350 to treat chronic idiopathic constipation (CIC).
The C-bar is a chewable bar offered in a range of flavours to deliver PEG-3350, an osmotic laxative.
It has been designed to offer a convenient, portable, and palatable daily dose of PEG-3350.
The open-label, proof-of-concept Phase Ib trial is designed to evaluate the safety and efficacy of a daily dosage regimen of C-Bar.
The trial will involve 25 adult male and female patients who are afflicted with CIC and currently being administered with a single daily dose of MiraLAX (polyethylene glycol).
During the trial, the patients will undergo a single dosage regimen of 17g of PEG-3350 in a single C-bar on a daily basis for two weeks.
The trial is primarily focused to evaluate the safety, efficacy and tolerability of PEG-3350.
ColonaryConcepts co-founder Brigham and Women’s Hospital Crohn’s and Colitis Centre director and Harvard Medical School faculty member Joshua Korzenik said: “We believe we can simplify the steps required for patients to take their prescription, make it far more palatable, and ultimately, more effective.
“Our deep patient experience tells us that there is a real demand for a better approach, especially as the incidence of constipation escalates.”
Based on the results of this study, the company will conduct the Phase II trial of CIC, expected to begin at the end of this year.