20.02.2020 – COSMO Pharmaceuticals N.V.

Cosmo announces very successful outcome of first GI GENIUS™ Investigator Initiated Study

Cosmo announces very successful outcome of first GI GENIUS™ Investigator Initiated Study

Dublin, Ireland – February 20, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced the very positive results of the first investigator initiated prospective clinical study of its GI Genius™ intelligent endoscopy device. GI Genius™ is the first system using artificial intelligence to detect colorectal polyps and is already commercialized in Europe.

The study was conducted at 3 Italian hospitals and enrolled 685 FIT + patients 40 to 80 years-old undergoing colonoscopy for CRC primary screening or surveillance. Patients were randomized 1:1 between HD colonoscopy with GI Genius™ and standard HD colonoscopy alone. The colonoscopies were performed by highly experienced endoscopists. The study endpoints were the Adenoma Detection Rate (ADR) and the Adenomas Per Colonoscopy (APC), also according to morphology, size, site, histology and withdrawal time (WT). To ensure maximum quality of the study, a minimum WT of 6 minutes was set, in accordance with American and European endoscopy guidelines.

700 patients were randomized and 685 were included in the final analysis (age: 61.32±10.2 years old; gender M/F: 337/348). The ADR (Adenoma Detection Rate) was significantly higher in the GI Genius™ group than in the control group (56.9% vs 40.9%, respectively; OR [95% CI]: 1.9 [1.4, 2.57]; p<0.001), as well as the APC (Adenoma Per Colonoscopy) (1.13±1.63 vs 0.73±1.12, respectively; OR [95% CI]: 2.1 [1.6 to 2.72]; p<0.001). The main reason of the difference between the two groups was the performance of GI Genius™ in the detection of small lesions (<10 mm: 1.39±1.71 vs 1.07±1.31; p<0.0001) and flat lesions (1.8±1.9 vs 1.19±1.5; p<0.0001). No difference in withdrawal time (GI Genius: 417±101 sec vs control: 435±149; p=0.1) was observed. The study thus showed that the use of GI Genius significantly increases ADR and APC, compared to the standard of care (HD colonoscopy).

The abstract of the study titled “Real Time Computer aided Diagnosis for Detection of Colorectal Neoplasia at Colonoscopy” has been selected by the ASGE Annual Scientific Program Committee for a lecture presentation during Digestive Disease Week® (DDW) at McCormick Place in Chicago, IL, May 4, 2020 at 4 PM.

Cesare Hassan, Head of Endoscopy, Department of Gastroenterology of Nuovo Regina Margherita Hospital in Rome and one of the investigators in this trial said: “The accuracy showed by GI Genius in experimental testing with polyp recognition has now led to a very significant increase in the detection of colorectal neoplasia in the first randomized trial. This indicates that the use of AI systems will result in an additional efficacy of screening colonoscopy for CRC prevention”.

Alessandro Della Chà (CEO of Cosmo) commented: “This is the first completely independent prospective study for GI Genius and the results are excellent. We have already seen in retrospective studies, where GI Genius analysed recorded videos of colonoscopies, that the system is highly reliable and able to detect the polyps which were detected at the time of the procedure plus additional polyps undetected at the time of the recorded procedure. This study now proves that the performance of GI Genius is maintained in real everyday practice. The results achieved in this study are so far the most relevant for this kind of devices, as the baseline ADR of the control arm (40.9%) largely exceeded the minimum requirement of the ASGE (25% minimum in the overall population). The system was able to increase such already high ADR by +16% in absolute value. Also, the device proved to be very effective in significantly increasing the number of detected adenomas per colonoscopy. As the largest study on ADR demonstrated that every 1% increase in ADR is associated with a 3% reduction in risk of interval colorectal cancer and 5% reduction in colorectal cancer deaths, we strongly believe that the routine use of GI Genius in clinical practice will provide a strong and reliable tool against CRC.”

The trial needed for the registration of GI Genius in the US has started and is expected to last approximately 4-6 months. Further updates will be timely provided.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo has licensed Aemcolo to Red Hill Biopharma and is the licensee for US of the novel agent for procedural sedation, Remimazolam, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com


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Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70


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