Norgine B.V., a European specialist pharmaceutical company, announced that the European DAYB study that compares Plenvu (NER1006) to a magnesium salt solution (Citrafleet) using a day before only dosing regimen met both primary endpoints and all secondary endpoints. In the study, Plenvu demonstrated non-inferiority in overall bowel cleansing success and achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon. These data were presented at United European Gastroenterology Week (UEGW) 2016.
The study met all of its secondary endpoints demonstrating non-inferior adenoma and polyp detection rates in both the overall colon and ascending colon.
Plenvu has been developed to provide overall bowel cleansing in adults, with an additional focus on the ascending colon. Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. Visualisation of the ascending colon is important because adenomas and polyps in this area are often more difficult to see than those in other areas of the colon.
Plenvu demonstrated an acceptable safety profile in day-before split-dosing administration.
The Plenvu phase III clinical trial programme includes three multicentre randomised parallel group studies: NOCT, MORA, and DAYB.
Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with 412,000 new diagnoses of colorectal cancer diagnosed every year.
Dr Alastair Benbow, chief development & medical officer, Norgine said, “These data are important because they demonstrate that Plenvu is an effective bowel cleanser and enables better detection of adenomas and polyps. Plenvu offers patients a new colorectal screening alternative that could improve their health outcomes and ultimately reduce the cost of healthcare systems.”
Plenvu (NER1006) is a novel, low-volume (1L) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. This low-volume solution is developed not only to 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.
Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split-dosing administration: Results from the phase III study DAYB.
This phase 3, randomised, multicentre, colonoscopist-blinded, non-inferiority study assessed the efficacy, safety and tolerability of a day before split-dosing regimen of either NER1006 (evening time) or sodium picosulfate + magnesium citrate (SPM: regimen per label) in patients undergoing colonoscopy. Two alternative primary endpoints were evaluated: overall bowel cleansing success and ‘Excellent plus Good’ cleansing rate in the ascending colon including the caecum using the Harefield Cleansing Scale (HCS). Secondary endpoints included hierarchical evaluation of adenoma/polyp detection rates, and cleansing assessment using the Boston Bowel Preparation Scale (BBPS). Patient tolerability, acceptability and compliance were assessed using a questionnaire. Safety was monitored through adverse events reporting and clinical laboratory evaluation. The threshold for statistical significance in this study was P<0.025. The confidence interval for the difference between the groups used a 10% margin to demonstrate non-inferiority vs. SPM.
NOCT study. A US study that compares Plenvu versus a trisulfate bowel cleansing solution (Suprep) using a 2-day split-dosing regimen in adults. Both primary endpoints were met, achieving non-inferior overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS). Plenvu demonstrated an acceptable safety profile.
MORA study. A European study that compares Plenvu versus a 2L PEG (Moviprep) with ascorbate bowel cleansing solution using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The study met both primary endpoints showing that when administered as either a 2-day overnight or 1-day morning split-dosing regimen, and compared to 2L PEG, Plenvu was non-inferior in achieving overall bowel cleansing, and non-inferior and superior in achieving ‘Excellent plus Good’ cleansing of the colon ascendens. Plenvu demonstrated an acceptable safety profile.
DAYB study. A European study that compares Plenvu versus a sodium picosulfate and magnesium salt solution (Citrafleet) using a day before only split-dosing regimen in adults. Although the study met both primary endpoints, demonstrating non inferiority, the data will contribute to safety evaluation only. The study used a dosing schedule for the comparator that is not relevant to current medical practice in US Plenvu demonstrated an acceptable safety profile.