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  • For the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis or chronic pancreatitis

MS1819 is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819 is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. By doing so, MS1819 offers the potential to provide CF and CP patients with a safe and effective therapy that enables them to control EPI and achieve the nutrition necessary for healthy growth, weight maintenance and good lung function.

Additionally, MS1819 offers key potential advantages over the current standard of care therapy for EPI, pancreas enzyme replacement therapy or PERT.   

First, PERT medications are made from the pancreases of pigs.  This presents both manufacturing challenges (PERT is reliant on pig stocks, which are often sourced from China and can be impacted by infection, including Swine flu) and patient preference issues (CF patient groups have expressed concern with pig-based medications).  Comparatively, MS1819 synthetic lipase does not contain any animal products and is made from a highly abundant resource.

Second, PERT medications require patients to take as many as 40 capsules per day to control EPI symptoms.  This “pill burden” is substantial and often results in patient non-compliance.  MS1819 offers the opportunity to substantially reduce the number of pills required to manage EPI.

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Exocrine Pancreatic Insufficiency

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement therapy (PERT) pills.

Cystic Fibrosis

Cystic fibrosis (CF) is a life-threatening genetic disease that primarily affects the lungs and digestive system. An estimated 30,000 children and adults in the U.S. (70,000 worldwide) have CF.

In people with CF, a defective gene and its protein product cause the body to produce unusually thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections. It also obstructs the pancreas and stops natural enzymes from helping the body break down food and absorb vital nutrients.

Chronic Pancreatitis

Chronic pancreatitis is inflammation of the pancreas that does not heal or improve, gets worse over time, and leads to permanent damage. People with chronic pancreatitis are unable to digest fat and key elements of food.