Date: 2014-10-20
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA
Company: Norgine Pharma (The Netherlands)
Product: NER1006
Action
mechanism: 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 should not only 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.
Disease: patients undergoing screening, surveillance or diagnostic colonoscopy
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Country:
Trial details:
Latest
news: * On October 20, 2014, Norgine announced that the Phase II study of its novel, low volume bowel preparation, NER1006, presented at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA, has met its primary efficacy end point of stool weight and co-primary endpoint of cleansing success. The study demonstrated high quality bowel cleansing efficacy with NER1006 vs. MOVIPREP® in screening colonoscopy patients. ( Halphen M, et al. Pharmacodynamic and clinical evaluation of low-volume polyethylene glycol based bowel cleansing solutions (NER1006) using split dosing in healthy and screening colonoscopy subjects. ACG 2014 abstract #P330) The Phase II open-label, randomised study (OPT, n=240) investigated the pharmacodynamics (stool weight), clinical efficacy and tolerability of dose and taste-optimised low-volume PEG-based formulations (NER1006), after split dosing, compared with Moviprep®. Results demonstrate that NER1006 achieved high quality bowel cleansing in screening colonoscopy patients, comparable with Moviprep®. Cleansing success rates were 90-100%. Stool output was consistently higher with NER1006, and safety and tolerability profiles between treatments were comparable. In addition, most subjects in the NER1006 arms reached clear effluent. Norgine has now enrolled the first patient into the first study of its Phase III programme, NOCT, a US study. The Phase III programme consists of three clinical trials: NOCT is a multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms, MORA and DAYB are European studies to further investigate the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006.
