LuMeBlue is a novel application of methylene blue, a coloring agent that is used to stain the mucosa to discover pre-cancerous lesions and polyps in the colon. The objective is to deliver methylene blue along the length of the entire colon via the MMX® technology thus enabling endoscopists to better detect pre-cancerous and cancerous lesions and polyps throughout the entire colon.The Company has completed an extensive phase III trial in 18 leading centers in North America and Europe. The full analysis set (FAS) covered 1205 subjects, the per protocol set 1137. The primary endpoint was to achieve superiority over standard of care, this being high definition white light endoscopy. This primary endpoint was attained by demonstrating that 17.7% more patients with adenomas were detected than in the Standard of Care arm (p value 0.009).
In the full analysis set (FAS) 479 subjects were treated in the Standard of Care arm of which 61.6% were males; 47,8% were first time screening colonoscopies, 6,3% were surveillance colonoscopies less than two years since the last colonoscopy and 45,9% were surveillance colonoscopies after more than 2 years following the first time colonoscopy. 61% were subjects in Europe.
485 in the LuMeBlue arm of which 60.6% were males, 48% were first time screening colonoscopies, 5,8% were surveillance colonoscopies less than two years since the last colonoscopy and 46,2% were surveillance colonoscopies after more than 2 years following the first time colonoscopy. 61,2% were subjects in Europe.
The Company intends to file the NDA for LuMeBlue in H1 2017 and intends, upon its approval to market LuMeBlue in the USA itself. Licensing/distribution partners will be sought in the rest of the world.