Anthera Pharmaceuticals, Inc. announced that it is actively recruiting participants for its new Phase 3 clinical study on Cystic Fibrosis, called SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin). The study is designed to further test the company’s investigational product that addresses issues related to digestion and absorption of nutrients in CF patients.
As part of the new study, Anthera will evaluate both the efficacy and safety of Sollpura® (liprotamase), an investigational pancreatic enzyme replacement therapy (PERT) that uses three biotechnology-derived digestive enzymes to treat patients with endocrine pancreatic insufficiency in comparison with an already approved therapy based on a porcine-derived, enteric-coated product. Endocrine pancreatic insufficiency disorder is characterized by deficiency of exocrine pancreatic enzymes, leading to patients’ inability to digest food properly. The most common cause of endocrine pancreatic insufficiency is cystic fibrosis, a genetic disorder characterized by the buildup of thick, sticky secretions in various organs, including the lungs, pancreas, liver and intestines. While mucus accumulation in cystic fibrosis patients’ lungs causes impaired breathing and chronic life-threatening infections, it also prevents digestive pancreatic enzymes from reaching the small intestine, causing serious digestive problems, notably exocrine pancreatic insufficiency.
The SOLUTION clinical trial will seek to determine whether liprotamase’s therapeutic benefits are not inferior to the commercially available PERT in a population enriched for PERT responders. This will be determined by measuring and comparing the therapies’ efficacy based on a change in the coefficient of fat absorption (CFA). Further information on the SOLUTION clinical trial can be found here.
Dr. Colin Hislop, Anthera’s Chief Medical Officer noted, “The initiation of the SOLUTION clinical study marks a critical milestone for Anthera. With its solubility, stability, and absence of bulky enteric coating, we believe Sollpura has the potential to significantly improve the lives of people with EPI. We are extremely excited to advance the Sollpura development program, and today we have taken another step towards making a much needed treatment available for people who are unable to maintain appropriate nutritional health with existing enzyme therapies.”
Paul F. Truex, Anthera’s President and Chief Executive Officer added, “We extend our sincere appreciation to the Cystic Fibrosis Foundation for their continued support of this program. They have been an invaluable resource throughout the development of the SOLUTION study. We look forward to their continued support as we further the development of Sollpura.”
Anthera Pharmaceuticals will discuss the SOLUTION clinical trial during the North American Cystic Fibrosis Conference on Friday October 9th, 2015 from 8:00 to 10:00 PM. The event will be held at the Sheraton hotel, 340 N 3rd Street, Phoenix, Arizona and those who woud like to attend can contact Nikhil Agarwal at [email protected] prior to Wednesday, October 7th, 2015.