Pancreatitis exacts a large morbidity and economic toll, causing over 300,000 hospitalizations per year in the United States, the most for any gastrointestinal disease, and accounting for over $2 billion annually in direct medical costs. Importantly for potential SBP-102 indications, recurrent episodes of pancreatitis may lead to chronic pancreatitis. Patients with a single episode of acute pancreatitis have a 20-30% likelihood of one or more recurrent episodes, with progression to chronic pancreatitis in an estimated 10% of the recurrent cases. Chronic pancreatitis is a disease characterized by a chronic inflammatory and fibrotic response that ultimately results in destruction of the exocrine and endocrine tissue. The natural history of chronic pancreatitis includes pain, nutrient maldigestion and diabetes. Glucose intolerance and diabetes mellitus are observed as disease progresses with an incidence over 50% in patients with long-standing chronic pancreatitis. The associations between chronic pancreatitis, diabetes and pancreatic cancer are of critical importance. Diabetes and chronic pancreatitis are well-established risk factors for pancreatic cancer. A study from Taiwan reported Hazard Ratios (HRs) of 5.22-7.59 for the risk of developing pancreatic cancer in patients with diabetes; an HR of 19.2 in patients with chronic pancreatitis; and a HR of 33.52 in patients with both diabetes and chronic pancreatitis. These results indicate that prevention of recurrent pancreatitis could have a dramatic beneficial effect on outcomes in the pancreatitis population.

There are no therapies available to halt recurrent pancreatitis and the resulting outcomes listed above. Sun BioPharma has begun exploration of a potential role of SBP-102 for the treatment of patients with recurrent acute and chronic pancreatitis.