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ARTICLE | Clinical News

Anthera discontinues development of Sollpura

March 23, 2018 6:32 PM UTC

Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) discontinued development of Sollpura liprotamase (LY3031642) after the candidate missed the primary endpoint in the Phase III RESULT trial to treat exocrine pancreatic insufficiency due to cystic fibrosis. The company said it will evaluate all strategic alternatives.

The open-label, international trial enrolled 140 patients ages ≥7 who were well controlled on stable porcine-derived pancreatic enzyme replacement therapy (PERT). Oral Sollpura missed the primary endpoint of non-inferiority to an approved porcine-derived PERT in the change from baseline to week eight in coefficient of fat absorption (CFA). The mean treatment difference in the change from baseline in CFA was 14.3%. Sollpura met the secondary endpoint of non-inferiority to PERT in the change from baseline to week eight in coefficient of nitrogen absorption (CNA) (mean treatment difference of 1.53%)...

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Lipase