Anthera Pharmaceuticals, Inc. (ANTH)

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Anthera Pharmaceuticals Announces Continuation of SIMPLICITY Study of Sollpura™ Following Positive DMC Review
Date : 12/13/2016 @ 8:30AM
Source : GlobeNewswire Inc.
Stock : Anthera Pharmaceuticals, Inc. (MM) (ANTH)
Quote : 1.79 0.0 (0.00%) @ 8:38AM


Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced that the Data Monitoring Committee (DMC) completed its pre-planned safety review of the SIMPLICITY clinical study of Sollpura supplied as a powder for oral solution in an initial cohort of cystic fibrosis patients seven years of age and older with exocrine pancreatic insufficiency. The DMC was in unanimous agreement “that there are no safety concerns and that the study can move forward to enrolling Part B,” which will enroll patients from 28 days to 6 years of age.

The SIMPLICITY study evaluates the safety and efficacy of Sollpura powder for oral solution which supplies the digestive enzymes in sachets that are dissolved into water or apple juice and drunk with meals. This study is being conducted in 2 parts in patients with exocrine pancreatic insufficiency due to cystic fibrosis. An initial evaluation of safety in patients aged 7 years and older has been completed before commencing enrollment of younger patients aged 28 days to 6 years into Part B.

Anthera can now begin screening and enrollment activities for Part B of the SIMPLICITY study following the positive outcome of the DMC review. In Part B, Sollpura powder for oral solution will be administered to pediatric patients ranging in age from 28 days to 6 years. Efficacy will be measured based on the observed coefficient of fat absorption following seven weeks of open-label treatment with Sollpura.

Anthera plans to report topline data including efficacy and safety data in the second quarter of 2017. Topline data from the Phase 3 SOLUTION clinical study evaluating the efficacy and safety of the capsule formulation of Sollpura remains on track for this quarter.