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

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]

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.

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.