Cosmo announces success in clinical trial of Eleview™ against standard of care in endoscopic mucosal resection of large sessile polyps in the colon

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  • Eleview requires less volume injected
  • Eleview requires less time
  • Less number of resection pieces with Eleview
  • Less reinjections necessary

Dublin – May 8, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced successful results of its randomized, double blind, multicentre, parallel arms clinical trial in the USA and Europe. The study was aimed to assess the effectiveness and safety of Eleview™ in comparison to a standard saline solution in subjects undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions ≥20 mm. The study was a “first in human” exploratory study and, even though it was not powered to show statistical significance, several endpoints were statistically significant in favour of Eleview™, with all other trending in favour of Eleview™.

The principal investigators, among the world’s top endoscopists, were D. Rex, Indiana University, Indianapolis; M. Wallace, Mayo Clinic Jacksonville; P. Sharma, University of Kansas City, Kansas City; A. Repici, Istituto Clinico Humanitas, Milano; P. Bhandari, Solent Center for Digestive Diseases, Portsmouth (UK).

The primary endpoints were divided into:

  • Efficacy Endpoints
    • Total injected volume needed to complete the EMR procedure
    • Total injected volume per lesion size
    • Time to resect the lesion completely
  • Safety Endpoints
    • Procedural complications assessed by:
      • Intra-procedural bleeding
      • Early (<24h) and delayed (≥24h post EMR) post-procedural bleeding
      • Perforation
      • Post-Polypectomy Syndrome
      • Hospital admissions for any post-procedural clinically relevant complication

The secondary endpoints were:

  • Sydney Resection Quotient: calculated by dividing the lesion size (in mm) by the number of resections required to remove the lesion
  • Injected volume needed to provide an initial lift
  • Number of re-injections
  • Number of resection pieces
  • Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult
  • Proportion of subjects with en bloc resection
  • Number of single session complete removal of lesions
  • Need for additional treatment modality for coagulation, avulsions or ablation

226 patients were enrolled, the per protocol population used in the primary analysis set was 211. Most patients were referred to the investigators for the potential complexity of their case. For this reason, the lesions’ size and location varied greatly. The mean lesion size in the Eleview™ arm was 31.64 mm but ranged from 20 mm to 100 mm. In the comparator arm, the mean lesion size was 32.31 mm with ranges from 20 mm to 70 mm. The location varied from the caecum to the rectum, with the majority in the right section of the colon (typically the most difficult to reach and challenging for polyp removal).

All primary endpoints were in favour of Eleview
The mean total injected volume in the Eleview™ arm was 16.1 ml (range 3-41). In the comparator arm 49.2% more liquid had to be injected with the mean volume reaching 31.6 ml (range 4-248).

The total injected volume per lesion size was 0.53 ml per mm (range 0.09-1.75). In the comparator arm 42.4% more volume per mm was needed with the volume per lesion size reaching 0.92 ml per mm (0.2-4.96). Both these endpoints reached statistical significance (p <0.001).

The time to resect the lesion was notably lower in the Eleview™ arm with mean time taking 19.15 minutes (1-100) while it took 35.5% longer in the comparator arm taking 29.7 minutes with ranges of 2-687 minutes, therefore showing that lesion removal with Eleview™ took one third less time.

All secondary endpoints were also in favour of Eleview, therefore confirming robustness of the overall data
The Sydney resection quotient (showing the ratio between the size of the lesion and the number of its pieces excised) was 28.8% higher in the Eleview™ arm than in the comparator therefore showing statistical significance (p 0.044).

When Eleview™ was used, the lesions were removed in fewer pieces (11.9% less than the comparator).

Eleview™ required on average the initial injection of lower volumes (10.4 ml) vs the comparator (15.3 ml)

58% more en bloc resections were possible with Eleview™ than with the comparator.

Substantially less re-injections were necessary when using Eleview (1.05) than comparator (1.79).

Safety
There was no difference in the number of complications between Eleview™ and the comparator. There was only one perforation, which occurred in the comparator arm. Eleview™ is at least as safe as the comparator in terms of procedural complications, even though it does not contain any vasoconstrictive drugs (epinephrine or norepinephrine) which are usually added to submucosal injectate to prevent immediate bleedings.

Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, commented: “The results of this trial clearly prove that Eleview™ is a substantial improvement over the saline solution. We are very pleased that we can now start marketing this unique product in the US market through our subsidiary Aries and provide endoscopists in the USA with a unique medical device that will make it possible for them to work faster and more efficiently than before with the only commercially available FDA cleared device”.

Eleviews marketing trial
Prof. Douglas Rex will present the results of the trial at the DDW on May 8, 2017.

Aries Presence at DDW
Aries be will at Digestive Disease Week (DDW) in Chicago, May 6-9, 2017, introducing Eleview™ to the gastroenterology community. The company will be exhibiting at Booth #2526 during the DDW and hosting nine product breakout sessions throughout the conference.

Eleview™
is a novel, ready to use, submucosal injectable composition for use in the easy and safe endoscopic removal of polyps, adenomas, and early stage cancers, and other lesions in the gastrointestinal (GI) tract. Eleview™ offers important benefits for gastroenterologists. Upon injection, the product forms an immediate cushion of optimal shape, height and duration. The inclusion of methylene blue, a contrast dye, improves visibility of the lesion. By providing an immediate and long-lasting cushion beneath the polyp and improving the visibility of the lesion, Eleview™ may help achieve a complete and safe removal of the lesion. Eleview™ is sterile, ready to use with commercially available endoscopic needles. It was approved by the FDA as a class II medical device and is the only approved medical device for this indication.

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 completed clinical trials of 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

Next events
Annual General Meeting                                             Amsterdam, May 24, 2017
Jefferies Global Health Care Conference                  New York, June 7-10, 2017
Half-Year Results                                                        July 28, 2017

Contact
Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.                       
Tel: +353 (1) 8170 370
ctanner@cosmopharma.com

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