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Phase 2b trial begins for edible colonoscopy prep

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Sebela Pharmaceuticals plans to begin a phase 2b clinical trial of an edible colonoscopy preparation kit this quarter, according to a press release.

EC Prep, developed by ColonaryConcepts, includes edible bars and beverages containing PEG 3350 and electrolytes, with the goal of improving patient experience and compliance in preparing for a colonoscopy

“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,” Douglas K. Rex, MD, trial investigator, professor of medicine and director of endoscopy at Indiana University School of Medicine, said in a press release. “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.”

The phase 2b trial will evaluate the safety and efficacy of EC Prep vs. a commonly used bowel prep product. After completion, Sebela plans to conduct phase 3 trials in the first half of 2018, and expects it may submit a new drug application in 2019.

Sebela acquired global rights to EC Prep earlier this year, as well as development and commercialization responsibilities.

“We are pleased that Sebela is accelerating with the clinical development of EC Prep,” Herbert Stern, CEO of ColonaryConcepts, said in the press release. “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.”

ColonaryConcepts, which was founded by gastroenterologists who felt available colonoscopy prep options were unsatisfactory, is also developing other products within its patient-friendly technology platform, including a novel chronic constipation treatment called C-Bar. They successfully completed a phase 1 study of this product earlier this year, and are planning a phase 1b study in early 2018.

Disclosures: Rex reports he is a consultant for ColonaryConcepts. Stern is employed by ColonaryConcepts.