HAYWARD, Calif., Feb. 05, 2018 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) is pleased to announce that the final patient has completed the last visit in the primary treatment phase of RESULT, a Phase 3 clinical study of Sollpura for exocrine pancreatic insufficiency (“EPI”) due to cystic fibrosis. Although the data remains blinded, two successful interim futility analyses were conducted by the independent Data Monitoring Committee which is comprised of experts appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network. During these reviews, no safety concerns were reported, and it was recommended that the study continue as planned. Top line data will be available later this quarter.
"We are just weeks away from top line data now that the final patient has completed the last treatment visit in the RESULT study,” remarked Craig Thompson, President and Chief Executive Officer at Anthera Pharmaceuticals. “Sollpura is one step closer to potentially providing the first oral, non-porcine pancreatic enzyme replacement therapy (PERT). We look forward to sharing the top line data once available."
“Data from the previous SOLUTION study and the solubility characteristics of Sollpura suggest that the higher dosing employed in the RESULT study will achieve non-inferiority to porcine PERTs,” shared Dr. Michael W. Konstan, deputy dean of the Case Western Reserve University School of Medicine in Cleveland. “The availability of an oral, non-porcine, alternative source for pancreatic enzyme replacement remains an important goal, and we look forward to the upcoming data."
The RESULT study enrolled 140 patients ages 7 to 58 years. Prior to randomization, the majority of patients were on Creon and 42% of patients were on gastric acid suppressants. Based on the outcome of the RESULT study, Sollpura has the potential to become the first oral, non-porcine PERT which may provide a reduction in the size and number of pills for patients with EPI.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency and B-cell associated renal diseases. Additional information on the Company can be found at www.anthera.com.
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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. Such 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, including but not limited to those set forth in Anthera's public filings with the SEC, including Anthera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. 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.
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Source: Anthera Pharmaceuticals, Inc.