Norgine today announced the enrolment of the first patient into the US Phase III study, NOCT, for its investigational product NER1006. This study will evaluate the bowel cleansing efficacy of a two-day split-dosing regimen of NER1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution (SUPREP(R)) in adult patients undergoing screening, surveillance or diagnostic colonoscopy. The NOCT study will also assess the compliance, safety, patient acceptability and tolerability of NER1006.
NER1006 is a novel, low volume polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. The dosing regimen of NER1006 (32 fl oz, of bowel preparation solution with 32 fl oz of extra water or clear fluid) aims to deliver a high level of efficacy. This low volume solution should not only support improved patient acceptability and compliance but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.[i]
The NOCT study is part of Norgine’s NER1006 Phase III clinical trials programme. NOCT is a US multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms. The Phase III programme also includes two clinical studies in Europe further investigating the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006. The MORA study will compare NER1006 versus MOVIPREP(R) using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will compare NER1006 versus a sodium picosulfate and magnesium salt
solution (CITRAFLEET(R)) using a day before only dosing regimen in adults. Enrolment for trials MORA and DAYB are planned to start in late 2014.
Donna McVey, Chief Development Officer, Norgine, commented: “We are excited about the clinical progress being made with NER1006, further strengthening our bowel cleansing portfolio which also includes MOVIPREP(R) and KLEAN-PREP(R). The acceptability of effective bowel cleansing products is critical for patients to ensure quality colonoscopy and avoid the need for repeat procedures.”
[i] Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer. A joint guideline from the American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy. The American Journal of Gastroenterology. 2014