Anthera Pharmaceuticals Inc.'s Sollpura failed to meet the primary endpoint in a phase 3 clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency, the inability to properly digest food due to a lack of digestive enzymes made by the pancreas.
The drug narrowly missed the primary endpoint for change in the coefficient of fat absorption non-inferiority margin. However, the drug displayed non-inferiority in the per protocol coefficient of fat absorption and coefficient of nitrogen absorption analyses.
Coefficient of nitrogen absorption is a measure of protein digestion and absorption and is a key requirement of Anthera's planned U.S. FDA regulatory submission. The company expects to release data from the extension phase of the study in the first quarter of 2017.
Sollpura was generally well-tolerated compared to Pancreaze, although symptoms related to malabsorption were generally modestly more frequent in the Sollpura arm.
Anthera expects to start a new study with adjusted doses in 2017 and only expects a modest delay in the filing of the biologics license application around the first quarter of 2018.