Phase III Clinical Trial Will Test Drug For Exocrine Pancreatic Insufficiency Associated With CF

Phase III Clinical Trial Will Test Drug For Exocrine Pancreatic Insufficiency Associated With CF

shutterstock_89242957Anthera Pharmaceuticals, Inc. announced a new agreement with DPx Holdings B.V. who will utilize their subdivision Patheon to support the manufacturing of Anthera’s lead drug Sollpura® for their upcoming Phase III clinical trial (SOLUTION).

Sollpura™ (liprotamase) is currently being tested for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), a condition characterized by disruption of the delivery of pancreatic digestive enzymes due to blockage of pancreatic ducts. EPI is often associated with cystic fibrosis, with approximately 90% of cystic fibrosis patients developing EPI. Cystic Fibrosis is caused by mutations in the Cftr gene (short for cystic fibrosis transmembrane conductance regulator). The CFTR protein is responsible for chloride and sodium ions being transported in and out of cells of the lung, but also the pancreas and intestinal epithelium. Thus, in the absence of CFTR functional protein, a thick mucus accumulates leading to blockage of affected organs’ passages, such as the pancreas exocrine ducts.

The Phase III SOLUTION clinical trial will enroll 126 patients to evaluate Sollpura™ (liprotamase) efficacy in treating EPI compared to other current therapies based on pancreatic enzyme replacement.

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Chuck Olson, head of Liprotamase Development noted, “This agreement represents the culmination of years of effort by Eli Lilly following their discussion with the U.S. FDA in 2010 to develop a next-generation therapy to address the unmet needs of patients with EPI as a result of cystic fibrosis. With this agreement, we’ve taken the first step towards delivering a soluble and stable, sachet-based, non-porcine Pancreatic Enzyme Replacement Therapy to patients burdened by currently available therapies. We look forward to working with Patheon, an experienced contract manufacturing organization, as we strive to bring this much-needed therapy to patients.”

Franco Negron, senior vice president, North America commercial operations and global integration at Patheon added,”Our agreement with Anthera illustrates the continued progress toward becoming a fully integrated partner of choice to global pharmaceutical and biotechnology companies. We look forward to working with Anthera on the commercialization of liprotamase.”

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