LONDON, UK, Friday 3 October 2014, 07:00 BST – Norgine today announced the enrolment of the first patient into the US Phase III study, NOCT, for its investigational product NER1006. This study will evaluate the bowel cleansing efficacy* of a two-day split-dosing regimen of NER1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution (SUPREP®) in adult patients undergoing screening, surveillance or diagnostic colonoscopy. The NOCT study will also assess the compliance, safety, patient acceptability and tolerability of NER1006.
NER1006 is a novel, low volume polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. The dosing regimen of NER1006 (32 fl oz**, of bowel preparation solution with 32 fl oz** of extra water or clear fluid) aims to deliver a high level of efficacy. 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.
The NOCT study is part of Norgine’s NER1006 Phase III clinical trials programme. NOCT is a US multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms. The Phase III programme also includes two clinical studies in Europe further investigating the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006. The MORA study will compare NER1006 versus MOVIPREP® using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will compare NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults. Enrolment for trials MORA and DAYB are planned to start in late 2014.
“Thorough bowel cleansing is vital to delivering an effective colonoscopy procedure. This pivotal study will not only evaluate the cleansing efficacy of NER1006, but also the tolerability of the preparation, a key factor in ensuring patient compliance and a successful procedure,” commented Michael DeMicco, MD and principal investigator, Anaheim Clinical Trails LLC, USA.
Donna McVey, Chief Development Officer, Norgine, commented: “We are excited about the clinical progress being made with NER1006, further strengthening our bowel cleansing portfolio which also includes MOVIPREP® and KLEAN-PREP®. The acceptability of effective bowel cleansing products is critical for patients to ensure quality colonoscopy and avoid the need for repeat procedures.”
The three, Phase III clinical studies are based on Phase II study ‘Pharmacodynamic and clinical evaluation of low-volume polyethylene glycol based bowel cleansing solutions (NER1006) using split dosing in healthy and screening colonoscopy subjects’. The results of the Phase II study are due to be presented at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA, 17-22 October 2014.
Notes to Editors
* The following primary endpoints will be investigated by the NOCT study:
The overall bowel cleansing success rate of NER1006 compared to SUPREP®, as graded by the Harefield Cleansing Scale (HCS), wherein success corresponds to Grades A and B, and failure corresponds to Grades C and D.
The “Excellent plus Good” cleansing rate in the colon ascendens of NER1006 compared to SUPREP® using the segmental cleansing scoring system of the HCS, wherein the ordinal score of 4 corresponds to “Excellent” and the score of 3 corresponds to “Good” cleansing.
** 32 US fluid ounce / approx. 1 litre
Phase II clinical programme
The open-label, randomised, 2-part (Part A: healthy subjects; Part B: screening colonoscopy subjects), Phase II study investigated the pharmacodynamics (stool weight), tolerability, and clinical efficacy of dose- and taste-optimised low-volume PEG-based formulations (NER1006) after split dosing compared with MOVIPREP®. The primary endpoint in Parts A and B was 24h stool weight (desired target ≥2750g). Cleansing success rate (Harefield Cleansing Scale) was a co-primary endpoint in Part B. Secondary endpoints included time and volume of study drug to reach clear effluent, safety and tolerability (including vomiting rate). 120 subjects were included in each part (n=30/arm). For subjects who completed dosing, vomiting rates were <7.0% and <3.5% for all treatments in Parts A and B, respectively, with no significant differences between arms in either part. In healthy and screening colonoscopy subjects, the new low volume, split-dose bowel preparation NER1006 achieved high quality bowel cleansing comparable with MOVIPREP®. Stool output was consistently higher with NER1006 treatments, and safety/tolerability profiles between treatments were comparable.
Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.
Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.
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.norgine.com
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Charlotte Andrews: Tel: +44 (0)1895 453669, Mob: +44 (0)7714 061485
Isabelle Jouin: Tel: +44 (0)1895 453643, Mob +44 (0)7714 061327
 Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer. A joint guideline from the American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy. The American Journal of Gastroenterology. 2014
 Halphen M, et al. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013;78:121-31