Dublin – July 24, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for LuMeBlue® (methylene blue), its drug aimed at enhancing the detection rate of adenomas.
LuMeBlue® Results In the trial LuMeBlue® was compared to Standard of Care (“WLHD”: White Light colonoscopy with High Definition endoscopes). The primary endpoint in the phase III trial was the number of subjects with at least one histologically proven adenoma or carcinoma. LuMeBlue® attained the primary endpoint identifying 17.71% more patients with adenomas or carcinomas than WLHD (p value 0.009; Relative Risk-RR-1.177). Adenomas were found in 56.3% of all subjects when using LuMeBlue®, whereas WLHD found adenomas in 47.8% of all subjects. LuMeBlue® therefore proves very efficient in flagging lesions.
In the phase III clinical trial the false positive rate (an important secondary endpoint) in the LuMeBlue® arm was lower than in the WLHD. In the LuMeBlue® arm 356 subjects out of 485 subjects had an excision. 83 of these subjects (23.3%) were false positives. In the WLHD arm 326 out of 479 subjects had an excision and 97 of these subjects (29.7%) were false positives. Thus LuMeBlue® finds more subject with lesions than WLHD, which subsequently prove to be more adenomas or carcinomas.
LuMeBlue® was also statistically superior and clinically very meaningful in the segment of subjects with 0-3 excisions, where 75%-80% of the patients are. In the segment of 0-3 excisions covering 362 subjects, the LuMeBlue® Adenoma Detection Rate (ADR) was 45.3%, while the ADR covering 376 subjects using WLHD was 35.9% (p value 0.0107). This is an improvement of 26.2% (RR 1.262).
There were no reported major drug related adverse events.
LuMeBlue® trial design The LuMeBlue® trial was conducted in 18 leading centers in 8 countries in North America and Europe. The Intention to Treat Population (ITT) was 1,249 subjects, the Full Analysis Set (FAS) was 1,205 subjects, the Per Protocol Set (PP) was 1,137 subjects and the safety set was 1,208 subjects. As agreed with the Regulatory Agencies, the endpoints were set according to FAS.
Four Clinical Research Organisations (CROs) were used: One CRO was responsible for the monitoring activities, one for the electronic CRFs, one for the bio-statistical activities and one for the high definition video recording activities and storing.
Two central histolabs, one each in the EU and one in the USA, were responsible for the histologic analysis of the excised tissues, 5 endoscopy centers, 2 in North America and 3 in Europe, were randomly assigned videos for review, and there was one endoscopy charter and one histology charter.
Subject population In the FAS 479 subjects were treated in the WLHD arm of which 61.6% were males; 47,8% were first-time screening colonoscopies, 6,3% were surveillance colonoscopies performed less than two years since the last colonoscopy and 45,9% were surveillance colonoscopies performed after more than 2 years following the first-time colonoscopy.
485 subjects were in the LuMeBlue® arm of which 60.6% were males, 48% were first time screening colonoscopies, 5.8% were surveillance colonoscopies performed less than two years since the last colonoscopy and 46.2% were surveillance colonoscopies performed after more than 2 years following the first-time colonoscopy.
241 subjects were treated in the confounding arm (not statistically powered).
About Cosmo Pharmaceuticals Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company has developed a medical device for polyp and adenoma excision and is has filed the NDA for LuMeBlue™, a diagnostic drug for the detection of colon cancer as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment®. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com
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