-Non-inferiority in overall bowel cleansing success
-Achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon
London, UK. Wednesday 19 October 2016, 08:00 BST. Norgine B.V. today 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™ is not yet approved for use.
Other data presented at UEGW included:
About PLENVU™ (NER1006)
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.
About the phase III clinical trial programme
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.
Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.
Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in Dreux, France.
For more information, please visit www.norgine.com
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
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 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 3 study DAYB. Abstract 1243. UEGW 2016
 Brenner H et al. Protection From Right- and Left-Sided Colorectal Neoplasms After Colonoscopy: Population-Based Study. J Natl Cancer Inst 2010;102:89-95
 Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915