Ireland-based Cosmo Pharmaceuticals N.V. (OTCMKTS: CMOPF) revealed that its Lumeblue (methylthioninium chloride) diagnostic agent has successfully completed a Phase III clinical trial in China. The trial was carried out by Cosmo’s partner, China Medical System Holdings Ltd (CMS; HKG: 0867).
Trial Design and Results
The randomized, double-blind, placebo-controlled trial compared Lumeblue to the standard of care in white light colonoscopy, aiming to determine safety, efficacy, and improvement in histologically confirmed non-polypoid colorectal lesions in subjects undergoing screening or surveillance colonoscopy for colorectal cancer (CRC). A total of 1,802 subjects were randomized, with the primary endpoint being the detection rate for non-polypoid colorectal lesions, which are the hardest to detect using standard technologies. Lumeblue met the endpoint with a strong degree of statistical significance: the proportion of patients with at least one histologically confirmed non-polypoid colorectal lesion was significantly higher in the Lumeblue group (445/872 subjects; 51.0%) compared to placebo (362/879, 41.2% – adjusted OR [95% CI]: 1.55 [1.27, 1.89]; P< 0.0001). Cosmo’s product also out-performed standard of care across an array of other secondary endpoints.
Partnership and Regulatory Milestones
CMS acquired Greater China rights to develop Cosmo’s Lumeblue in a 2020 deal. The oral diagnostic agent, specifically designed to improve pre-cancerous and cancerous detection of colorectal lesions during colonoscopy, was first approved in the EU in August 2020.-Fineline Info & Tech
