Cosmo Pharmaceuticals Announces First Patient Randomized In Its Proof Of Concept Phase II Clinical Trial Of Rifamycin SV in IBS-D

"We are excited to achieve this important milestone, that will contribute to expand our Rifamycin SV franchise to new indications" said Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals.

About the trial

This randomized, placebo controlled trial will investigate the efficacy and safety of two doses of Rifamycin-SV compared to placebo. The study will include three treatment arms; 600mg Rifamycin SV twice daily, 600 mg Rifamycin SV three times daily or placebo for a period of 2 weeks. Subjects must meet the established Rome IV diagnostic criteria for IBS-D before being randomized. The study will investigate the lasting treatment effects following a 2-week course of treatment during a 3-month follow up period. The primary endpoint will be the proportion of subjects who achieve adequate relief from both abdominal pain and diarrhoea. Relief of abdominal pain is defined for the trial by a decrease of at least 30% in the weekly average pain score, and a 50% or more reduction in the number of days per week with diarrhoea. These will be patient-reported outcomes using a personal electronic diary. The study will also investigate effects on patient reported bloating symptoms, frequency, feelings of urgency, and impact on Quality of Life, assessed by questionnaire. The trial will be conducted at 25 sites in Western Europe and will recruit 342 subjects, who will be randomized 1:1:1 into each of the 3 possible treatment arms.

Irritable Bowel Syndrome (IBS-D)

IBS is a very common functional bowel disorder that can result in abdominal pain, bloating, and altered bowel function (diarrhoea, constipation, or both). IBS-D is a subtype of the disordercharacterised by being symptomatically diarrhoea predominant. Estimates worldwide vary, but prevalence is high. Worldwide prevalence has been estimated at 10-20% for IBS, and up to 20% of the US population is affected by IBS. Studies report IBS frequently occurs in young adulthood, a key life period for education, establishing careers and establishing a family. The changes in bowel habit in IBS-D are frequently associated with a general physical malaise, and psychological disturbances such as panic attacks and/or generalised anxiety or mood disorders, although the link between IBS-D and these conditions is unclear.

Depending on severity, IBS-D can have a significant impact on quality of life, and healthcare costs can be high. Many sufferers of IBS-D never seek medical help. There is therefore a significant unmet medical need for more effective IBS-D treatments.

The bacterial overgrowth theory of IBS-D suggests that the excessive coliform bacteria in the small bowel give rise to the symptoms of IBS-D. The bacteria associated with overgrowth are of the colonic types, gram negative aerobes and gram-negative anaerobes that ferment carbohydrate into gas. A range of broad spectrum antibiotics including tetracycline, amoxicillin/clavulanate, metronidazole, and various fluoroquinolones have been used to reduce bacterial overgrowth and treat IBS-D. However, these compounds frequently have systemic side effects. There is growing interest in the role of altered bacterial flora contributing to the development of IBS, and the role of non-absorbable Ansamycin antibiotics in treating IBS-D.

Rifamycin SV has a wide spectrum of activity against the microbes implicated in bacterial overgrowth. Significantly, it is non-absorbed (minimal systemic side effects) and has a low resistance profile.

Cosmo is conducting this clinical study to test the safety and efficacy of Rifamycin SV, coupled with the MMX® drug delivery technology in the treatment of IBS-D.

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 formerly 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

Contact

John Manieri, Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 (1) 8170 370
jmanieri@cosmopharma.com