Phase III results for NER 1006 (1 litre PEG and ascorbate) meets primary endpoints in bowel preparation- Norgine

Norgine B.V. has announced new positive data from the phase III MORA study for NER 1006 (1 litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. 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, NER 1006 was non-inferior in achieving overall bowel cleansing, and non-inferior and superior in achieving 'Excellent plus Good' cleansing of the ascending colon. In addition, the study showed that as a 2-day overnight or 1-day morning split-dosing regimen, NER 1006 was non-inferior in detecting adenomas and polyps in the ascending and overall colon and as a 2-day overnight split-dosing regimen, it demonstrated a superior polyp detection rate in the ascending colon.

The overall tolerability and safety profile of NER 1006 was comparable to that of 2L PEG. Treatment related adverse events were mild or moderate in severity and reflected the expected safety profile of the respective treatments. NER 1006 is not yet approved for use. The data was presented at Digestive Disease Week. Norgine intends to submit NER 1006 for approval in the US and EU.