POSITIVE US PHASE III DATA SHOW EFFICACY OF PLENVU A LOW VOLUME PEG BASED BOWEL CLEANSING SOLUTION

London, UK. Wednesday 19 October 2016, 11:00 BST. Norgine B.V. today presented positive phase III data from the US based, NOCT study that compares the bowel cleansing efficacy of PLENVU^™ (NER1006) versus trisulfate bowel cleansing solution (SUPREP^®) in patients undergoing colonoscopy. The study met its primary endpoints demonstrating that when administered as a 2-day split-dosing regimen, PLENVU^™ was non-inferior in overall bowel cleansing success. It also achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon.[1]

These data were presented at United European Gastroenterology Week (UEGW) 2016.
 

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 overnight split-dosing administration.
 

The PLENVU^™ Phase III clinical trial programme includes three multicentre randomised parallel group studies: NOCT, MORA, and DAYB. 
 

In the US, colorectal cancer is the fourth most common cause of cancer-related mortality, with 136,119 people diagnosed in 2013.[3]^,[4] In Europe, colorectal cancer is the second most common cause of cancer-related mortality, with 412,000 new diagnoses of colorectal cancer diagnosed every year.[5]
 

Dr Alastair Benbow, Chief Development & Medical Officer at Norgine said, “These data are significant for patients because PLENVU^™ can enhance the detection of adenomas and polyps that frequently go undetected and often result in colorectal cancer. Improving the quality of screening will ultimately lead to better patient outcomes and can help reduce healthcare costs.”
 

He added, “As a novel and the only 1 litre solution, PLENVU^™ addresses the challenges faced by patients to comply with drinking higher volume, 2 and 3 litre, preparations.”
 

PLENVU^™ is not yet approved for use.
 

Other data presented at UEGW included:

• Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation PLENVU^™ (NER1006) versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: Results from the phase III study MORA. P0179, 17 October 2016, 10:30 – 17:00.
• Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation PLENVU^™ (NER1006) versus sodium picosulfate + magnesium citrate in day before split-dosing administration: Results from the phase 3 study DAYB. P1266, 19 October 2016, 09:00-14:00.

Ends
 

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 trisulfate solution in overnight split-dosing administration: Results from the phase III study NOCT

This phase 3, randomised, multicentre, colonoscopist-blinded, non-inferiority study assessed the efficacy, safety and tolerability of a 2-day overnight split-dosing regimen of either NER1006 (N2D) or trisulfate solution (TS) in patients undergoing colonoscopy. Two alternative primary endpoints were evaluated: overall bowel cleansing success and ‘Excellent plus Good’ cleansing rate in the colon ascendens using the Harefield Cleansing Scale (HCS). Secondary endpoints included hierarchical evaluation of lesion detection rates (key), and cleansing assessment using the Boston Bowel Preparation Scale (BBPS; supportive). Patient tolerability, acceptability and compliance were assessed using questionnaires. Safety was monitored through adverse events 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. TS.
 

About the phase III clinical trial programme

• NOCT study. A U.S. study that compares PLENVU^™ versus a trisulfate bowel cleansing solution (SUPREP^®) using a 2-day split-dosing regimen in adults. Both primary endpoints were met, achieving non-inferior overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS). PLENVU^™ demonstrated an acceptable safety profile.

• MORA study. A European study that compares PLENVU^™ versus a 2L PEG (MOVIPREP^®) with ascorbate bowel cleansing solution using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. 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, PLENVU^™ was non-inferior in achieving overall bowel cleansing, and non-inferior and superior in achieving ‘Excellent plus Good’ cleansing of the colon ascendens. PLENVU^™ demonstrated an acceptable safety profile.

• DAYB study. A European study that compares PLENVU^™ versus a sodium picosulfate and magnesium salt solution (CITRAFLEET^®) using a day before only split-dosing regimen in adults. Although the study met both primary endpoints, demonstrating non inferiority, the data will contribute to safety evaluation only. The study used a dosing schedule for the comparator that is not relevant to current medical practice in U.S. PLENVU^™ demonstrated an acceptable safety profile.

About Norgine

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.
 

NORGINE and the sail logo are trademarks of the Norgine group of companies.

Media Contacts

Isabelle Jouin, T: +44 (0)1895 453643

Charlotte Andrews, T: +44 (0)1895 453607

Follow us @norgine

GL/COR/1016/0081
October 2016