New Positive EU Phase III Data Show Efficacy of PLENVU™ (NER1006), a Low Volume, PEG Based Bowel Cleansing Solution

LONDON, October 19, 2016 /PRNewswire/ --

-Non-inferiority in overall bowel cleansing success  

-Achieved an 'Excellent plus Good' cleansing rate in the ascending colon 

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.

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The study met all of its secondary endpoints demonstrating non-inferior adenoma and polyp detection rates in both the overall colon and ascending colon. ^[1]

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. ^[2]

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.

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.

View the full release on http://www.norgine.com

1. 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

2. 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

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