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Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Porcine Origin in People With Cystic Fibrosis

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Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced the initiation of the SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in People With Cystic Fibrosis) Phase 3 clinical study evaluating the efficacy and safety of Sollpura® (liprotamase), a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency (EPI).

The Phase 3 SOLUTION clinical study is a multicenter, randomized, open-label, assessor-blind, non-inferiority, active-comparator study designed to evaluate the efficacy and safety of Sollpura in people with EPI due to cystic fibrosis. This pivotal study is intended to evaluate the non-inferiority of Sollpura compared with a commercially available PERT in a population enriched for PERT responders. The primary efficacy endpoint of this study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) at the end of therapy. For more information on the SOLUTION clinical study, please visit https://clinicaltrials.gov/ct2/show/NCT02279498.

"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," said Dr. Colin Hislop, Anthera's Chief Medical Officer. "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."

"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," said Paul F. Truex, Anthera's President and Chief Executive Officer. "We look forward to their continued support as we further the development of Sollpura."

Results from the SOLUTION clinical study are anticipated to support marketing approval for Sollpura as a treatment for exocrine pancreatic insufficiency.

On Friday October 9th, 2015 from 8:00 to 10:00 PM, during the North American Cystic Fibrosis Conference, Anthera will host a reception to discuss the SOLUTION clinical study with Sollpura. The reception will be held at the Sheraton hotel, 340 N 3rd Street, Phoenix, Arizona. To receive an invitation to the event, please contact Nikhil Agarwal at nagarwal@anthera.com, prior to Wednesday, October 7th, 2015.

Posted-In: News FDA Press Releases

 

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