New Positive Phase III Study for NER1006 - The First 1 Litre PEG-Based Bowel Preparation

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LONDON, May 24, 2016 /PRNewswire/ --

• Study met both primary endpoints demonstrating non-inferiority in overall bowel cleansing and superiority in 'Excellent plus Good' cleansing of the ascending colon 

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Norgine B.V. today announced new positive data from the phase III MORA study for NER1006 (1 litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. 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, NER1006 was:

• Non-inferior in achieving overall bowel cleansing
• Non-inferior and superior in achieving 'Excellent plus Good' cleansing of the ascending colon

In addition, the study showed that as a 2-day overnight or 1-day morning split-dosing regimen, NER1006 was non-inferior in detecting adenomas and polyps in the ascending and overall colon and as a 2-day overnight split-dosing regimen, it demonstrated a superior polyp detection rate in the ascending colon.

The overall tolerability and safety profile of NER1006 was comparable to that of 2L PEG. Treatment related adverse events were mild or moderate in severity and reflected the expected safety profile of the respective treatments.

The threshold for statistical significance in this study was P<0.025 and a 10% margin was used to demonstrate non-inferiority vs. 2L PEG. ^[1]

Peter Martin, Norgine's Chief Operating Officer, said: "The new positive phase III MORA results for NER1006 are promising because we know that the quality of a bowel preparation is an important factor for a successful colonoscopy and detecting polyps and tumours. These data reinforce Norgine's leadership in colonoscopy to provide patients with innovative treatments."

NER1006 is not yet approved for use. Norgine intends to submit NER1006 for approval in the US and EU.

The data was presented at Digestive Disease Week on 24 May 2016, 09:30-16:30.

To view the full press release go to http://www.norgine.com

References 

1. Raf Bisschops, Jonathan Manning, Lucy Clayton, Richard Ng Kwet Shing, Marco A. Alvarez-Gonzalez (2016): Efficacy and Safety of the Novel 1L PEG and Ascorbate Bowel Preparation NER1006 Versus Standard 2L PEG With Ascorbate in Overnight or Morning Split-Dosing Administration: Results from the Phase 3 Study MORA. Gastroenterology, Vol. 150, Issue 4, S1269-S1270. Abstract Tu2084. 

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SOURCE Norgine B.V.