- Study to enroll approximately 130 patients with exocrine pancreatic insufficiency
- More than 50 clinical sites around the United States and Europe are expected to participate
- Anthera to host reception at the North American Cystic Fibrosis Conference to discuss the SOLUTION program.
HAYWARD, Calif., Oct. 2, 2015 (GLOBE NEWSWIRE) -- 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 email@example.com, prior to Wednesday, October 7th, 2015.
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.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. Additional information on the Company can be found at www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-Q for the quarter ended June 30, 2015. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc., firstname.lastname@example.org or 510.856.5600x5621Source:Anthera Pharmaceuticals, Inc.