Anthera Pharmaceuticals Announces Completion of Recruitment in the Phase III RESULT Clinical Study of Sollpura

The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study.

HAYWARD, Calif., Nov. 09, 2017 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that patient recruitment is now complete for the Phase 3 RESULT clinical study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency (“EPI”) caused by cystic fibrosis. Topline data is expected in Q1 2018.

“The support from patients, the cystic fibrosis community, our clinical study investigators and sites has been tremendous and we are very pleased with how quickly and efficiently the recruitment target was achieved,” shared Dr. William Shanahan, Chief Medical Officer, Anthera Pharmaceuticals. “We now look forward to reporting the interim futility analysis in December, followed by top line data in Q1 2018.”

The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study. As with current practice with porcine pancreatic enzyme replacement therapies (“PERT”), the RESULT study allows for dose increases of Sollpura on an individualized basis to achieve maximum therapeutic benefit. Sollpura has the potential to become the first non-porcine PERT, which may provide a reduction in the size and number of pills patients must consume daily due to the significantly more compact formulation of Sollpura than porcine PERTs.

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 IgA nephropathy. 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. 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.

CONTACT:

Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com

For Media Inquiries:
Frannie Marmorstein, 305-567-0821
frannie.marmorstein@rbbcommunications.com

www.twitter.com/antherapharma
https://www.facebook.com/antherapharma/
https://www.linkedin.com/company/anthera-pharmaceuticals

Source: Anthera Pharmaceuticals, Inc.

MORE ON THIS TOPIC