Achieving Successful Bowel Preparation (BBPS Score 2-3 per Segment) With Evening/Morning or Morning-Only Split-Dosing Regimens of NER1006 versus 2L Polyethylene Glycol With Ascorbate: Post hoc Analysis of a Phase 3 Trial: 2017 Presidential Poster Award

Abstract

Introduction: Effective colonoscopy requires effective bowel preparation. An adequate segmental cleansing level has recently been defined as 2 or more on the Boston Bowel Preparation Scale (BBPS).1 The Phase 3 trial MORA compared NER1006 as an evening/morning split-dosing or a morning-only dosing regimen, against 2L polyethylene glycol with ascorbate as an evening/morning split-dosing regimen (2L PEG +Asc). Treatment-blinded central readers assessed the bowel cleansing efficacy using both the Harefield Cleansing Scale (HCS) and the BBPS. This analysis shows the BBPS scores for the two primary endpoints, in those patients who had a readable colonoscopy. Methods: In the MORA trial,2 849 patients aged 18-85 were randomized to bowel preparation with morning-only dosing NER1006 or evening/morning split-dosing NER1006 or 2L PEG + Asc. Adequate level cleansing success was assessed according to the BBPS for both overall colon (all segments ≥2) and right colon cleansing (segmental score ≥2). The analysis includes all subjects for whom colonoscopy videos were available for assessment by central readers. Results: Data from 792 patients were analysed. When using evening/morning split-dosing, 249/262 (95%) patients on NER1006 achieved adequate level overall colon cleansing compared to 232/260 (89%) on 2L PEG + Asc (Table 1). For NER1006 morning-only dosing this cleansing outcome was: 243/270 (90%) patients. When using evening/morning split-dosing, 254/262 (97%) patients on NER1006 achieved adequate level right colon cleansing compared to 242/260 (93%) on 2L PEG + Asc. For NER1006 morning-only dosing this cleansing outcome was: 253/270 (94%) patients. Adequate level cleansing success was achieved significantly more often with NER1006 evening/morning split-dosing than 2L PEG + Asc, both in the overall colon (P=0.013) and in the right colon (P=0.042). The slight improvement seen with NER1006 morning-only dosing in the cleansing rate of the overall colon and right sided colon was not statistically significant.Table: Table. Adequate Level Cleansing of the Overall Colon and Right Colon (BBPS segmental scores 2-3) as Determined by Treatment-Blinded Central ReadersConclusion: NER1006 demonstrated an exceptionally high adequate level bowel cleansing efficacy. A significant improvement was shown for both the overall colon and the clinically relevant right sided colon versus 2L PEG + Asc when administered using the same dosing regimen. The morning-only dosing regimen of NER1006 delivered a very high success rate, similar to that of 2L PEG + Asc.