Dutch pharmaceutical firm Norgine has enrolled its first patient in NOCT, its US Phase III trial of its investigational product, NER1006, in adult patients undergoing screening, surveillance or diagnostic colonoscopy.
NER1006 is a new, low volume polyethylene glycol based bowel preparation developed to provide whole bowel cleansing, with an additional focus on the ascending colon.
The trial is designed to 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 these patients.
Compliance, safety, patient acceptability and tolerability of NER1006 will also be evaluated in the NOCT trial.
The dosing regimen of NER1006, 32 fl oz, of bowel preparation solution with 32 fl oz of extra water or clear fluid, is aimed at delivering high level of efficacy.
In addition to supporting improved patient acceptability and compliance, this low volume solution also contributes to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.
The US multicentre, randomised, parallel-group NOCT trial, which is part of the company’s NER1006 Phase III clinical trials programme, is expected to enrol 540 patients across two arms.
The Phase III programme also includes two clinical trials in Europe further investigating the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006.
The MORA trial will compare NER1006 versus MOVIPREP using a two-day split-doing regimen and a one-day morning split-dosing regimen in adults, while the DAYB trial will compare NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET) using a day before only dosing regimen in adults.
The company intends to commence patient enrolment in the MORA and DAYB trials later this year.
Norgine chief development officer Donna McVey said: "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."