The SIMPLICITY study evaluates the safety and efficacy of Sollpura powder for oral solution which supplies the digestive enzymes in sachets that are dissolved into water or apple juice and drunk with meals. This study is being conducted in 2 parts in patients with exocrine pancreatic insufficiency due to cystic fibrosis. An initial evaluation of safety in patients aged 7 years and older has been completed before commencing enrollment of younger patients aged 28 days to 6 years into Part B.
Anthera can now begin screening and enrollment activities for Part B of the SIMPLICITY study following the positive outcome of the DMC review. In Part B, Sollpura powder for oral solution will be administered to pediatric patients ranging in age from 28 days to 6 years. Efficacy will be measured based on the observed coefficient of fat absorption following seven weeks of open-label treatment with Sollpura.
Anthera plans to report topline data including efficacy and safety data in the second quarter of 2017. Topline data from the Phase 3 SOLUTION clinical study evaluating the efficacy and safety of the capsule formulation of Sollpura remains on track for this quarter.
About Sollpura (liprotamase)
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.
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Nikhil Agarwalof Anthera Pharmaceuticals, Inc.firstname.lastname@example.org or 510.856.5600 x5621
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