Norgine Presents New Post-hoc Data Analyses Highlighting the Efficacy of PLENVU® for Bowel Cleansing at DDW

LONDON, May 6, 2017 /PRNewswire/ --

Norgine B.V. today presented new post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of PLENVU^®, a low volume, 1 litre PEG and ascorbate bowel preparation when compared to sodium picosulfate with magnesium citrate (CITRAFLEET^®) and 2 litre PEG with ascorbate (MOVIPREP^®) respectively when using site colonoscopist assessments.^[1],[2] In addition, data from the DAYB study show that PLENVU^® achieved statistically significant improvements in adequate cleansing rates using the Boston Bowel Preparation Score when compared to sodium picosulfate with magnesium citrate.^[3]

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High cleansing efficacy:

• In the DAYB study, when compared to sodium picosulfate with magnesium citrate (CITRAFLEET^®) using a day before dosing, PLENVU^® achieved significantly better cleansing success;
  • in the overall colon (73.3% vs 60.9%, P=0.003)^[1]
  • and a high-quality cleansing of the ascending colon (36.3% vs 15.4%, P<0.001)^[1]
• In the MORA study, when compared to standard 2 litre PEG with ascorbate (MOVIPREP^®), PLENVU^® achieved a significantly improved rate of;
  • cleansing in the overall colon when administered as an evening/morning split-dose (97.0% vs 90.9%, P=0.003)^[2]
  • high-quality cleansing in the ascending colon when administered as an overnight split-dose (74.8% vs 60.9%, P<0.001) or morning-only dose (75.8% vs 60.9%, P<0.001)^[2]

Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate;

• PLENVU^® achieved a statistically significantly increased proportion of adequate level cleansing of the overall (61.9% vs 47.3%, P=0.001) and ascending colon (66.9% vs 50.2%, P<0.001) in patients with Boston Bowel Preparation Scale scores^[3]

PLENVU^® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.^[4],[5],[6]

Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented "These phase III data confirm the potential of PLENVU^®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU^® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources."

These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago.

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 and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.^[7],[8]

PLENVU^® data being presented at DDW on Saturday 6 May, 12:00 CDT

• Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1096
• Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1109
• Achieving adequate level bowel preparation with evening only dosing of novel NER1006 versus sodium picosulfate + magnesium citrate: post-hoc analysis from a randomized controlled trial. Poster Sa1120
• High cleansing efficacy of NER1006 also in the elderly; subgroup analysis of randomized phase 3 trials. Poster Sa1110

In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU^® in the US and Canada.

PLENVU^® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US.

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

1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017

2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017

3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017

4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219

5. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416

6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(Suppl1): A589-A590

7. Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915

8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]

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