The clinical trial was a randomized, placebo-controlled, parallel design conducted at Hospital la Timone in Marseille, France. The goal of the clinical trial was primarily to assess the safety profile and secondarily, to get early evidence of the clinical activity of the MS1819 recombinant lipase in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis.
“The study results are fully in accordance with our expectations”, stated Daniel Dupret, ProteaBio’s President. “The completion of our first clinical trial is an important milestone for this promising biotherapeutic, as well as for Protea.”
Lipase is an enzyme that is produced by the pancreas to digest fat. Chronic pancreatitis is defined as long term inflammation of the pancreas, characterized by irreversible changes in pancreatic cells. Causes of exocrine pancreatitis insufficiency (EPI) include cystic fibrosis, drug/alcohol abuse, pancreatic cancer and other conditions. Chronic pancreatitis causes chronic abdominal pain, impairment of hormone and digestive enzyme functions of the pancreas, and can produce serious weight loss. A lack of pancreatic enzymes results in the inability to properly digest food leading to malnutrition. Vitamin absorption (A, D, E, and K) is also impaired.
“We are very pleased to have completed this Phase I/IIA human clinical trial. We strongly believe that such a product could have a significant improvement in the treatment of exocrine pancreatic insufficiency”, stated Jean-Nicolas Vernin, Laboratoires Mayoly-Spindler ’s CEO.
The two companies plan to commence the phase II human clinical trial in 2012.