On December 27, 2016, Anthera Pharmaceuticals, Inc.(NASDAQ:ANTH) issued a press release announcing topline efficacy and safety data from the Company's Phase 3 SOLUTION clinical study with Sollpura in cystic fibrosis patients with exocrine pancreatic insufficiency.
Anthera Pharmaceuticals has dropped from $2.01 to $0.74, down 63.08% on the day.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency due to cystic fibrosis and IgA nephropathy. Additional information on the Company can be found at www.anthera.com.
Sollpura is a novel, non-porcine PERT containing a proprietary, biotechnology-derived formulation of cross-linked crystalline lipase, crystalline protease, and amorphous amylase with broad substrate specificity, that has been designed for purity (no potential for viral contamination), precise dose standardization, resistance against proteolysis without polymeric coating, and stability in acid pH for reliable potency of activity in the proximal small intestine. Sollpura represents potentially the first soluble, stable and non-pig derived enzyme product to offer a solution to people with EPI, including young children and adults, who are either unable to swallow multiple pills or are forced to use gastric tubes in order to maintain appropriate nutritional health. Unlike other enzyme products for the treatment of EPI derived from pig pancreas, the purified enzymes in Sollpura exhibit enhanced solubility and stability that make it an ideal product to be conveniently co-administered with a variety of liquids and food products.
The Phase 3 SOLUTION study was designed to evaluate the non-inferiority of Sollpura compared to approved, porcine-derived, enterically-coated pancreatic enzyme replacement therapy when administered to patients with exocrine pancreatic insufficiency due to cystic fibrosis. The study enrolled subjects with exocrine pancreatic insufficiency due to cystic fibrosis who were well controlled on stable PERT therapy prior to screening, as demonstrated by a coefficient of fat absorption (CFA) of at least 80%. The primary efficacy variable evaluated the change from baseline in CFA following 7 weeks of therapy with either Sollpura or an alternative porcine PERT to that being taken during screening. Individualized doses of Sollpura and the PERT comparator were chosen to match the lipase units of pre-study PERT. Additional adjustment of the study drug doses was allowed during the first 2 weeks of study based on clinical signs of malabsorption up to a maximum allowed dose of 10,000 units/kg/day of lipase. Subjects enrolled into the SOLUTION study will continue to be followed through Week 20 for additional assessments of safety and efficacy.