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GI ProDrugs Medicines for Inflammatory Bowel Disease Introduction: Inflammatory Bowel Disease (IBD) is a group of conditions of the colon and small intestine, of which Ulcerative Colitis (UC) and Crohn’s Disease (CD) are major types. GI ProDrugs are a group of proprietary treatments for IBD based on targeting technology developed at the School of Pharmacy and the School of Medicine at TCD. Chemical drug targeting involves the deliberate modification of a drug structure causing it to accumulate at the target tissue, enhancing the efficacy of the drug treatment whilst reducing systemic impact of side effects. IBD is a chronic disorder with significant morbidity in the form of diarrhea, weight loss and potentially serious and life-threatening complications. IBD is a common disorder – annual incidence of 1.2% and 0.63% for UC and CD, respectively, in the US and EU. In 2010 worldwide sales of the mesalazine class of drugs for UC amounted to $1.6B Concept: DRUG • • CARRIER LINKER • Enzymatic Cleavage – Specific to Colonic Microflora + • • • Oral NCE prodrug for delivery of steroid to the colon Primary indication: – Ulcerative Colitis Secondary Indication: – Crohn’s Disease Cleavage by colonic flora liberates steroid Less systemic toxicity compared to steroid alone Platform for delivery of other small molecules to colon LINKER DRUG CARRIER The Opportunity: •Large market Data: • Novel, colon-targeting, patent protected pro-drug technology • Proof of concept and proof of principle demonstrated in in vivo models • With dedicated resources anticipate ~18 months to the clinic • Clearly defined patient population and well designed clinical studies ready for execution GI ProDrug • Positive feedback from IBD thought leaders •Potential to expand platform to include next generation steroids for IBD and therapies for colorectal cancer Figure: Drug activity index score profile of DSS-induced colitis subjects 14 Researchers: Dr. John Gilmer and Prof. Dermot Kelleher [email protected] TTO Contact: Gordon Elliott [email protected]