Anthera Pharma Says Sollpura Misses Study Target

(RTTNews) - Anthera Pharmaceuticals Inc. (ANTH) announced the results of the SOLUTION clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). The study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat or mITT analysis; however, by additional pre-specified analyses of CFA (mITT-Baseline Observation Carried Forward and Per Protocol), Sollpura met the non-inferiority criterion.

The study also confirmed that the ratio of the three enzymes in Sollpura demonstrated an appropriate response in the coefficient of nitrogen absorption or CNA. CNA is a measure of protein digestion and absorption and is a key requirement of Anthera's planned US FDA regulatory submission. Anthera expects to release data from the extension phase of the study in the first-quarter of 2017.

In addition to the challenges to dose escalation inherent in the design of the SOLUTION study, analytical techniques for measuring the activity of lipase enzymes based on duodenal pH of Cystic Fibrosis patients, indicate that Sollpura may have been under dosed versus the Pancreaze labeled dose.

Given the robust activity of Sollpura in this study, in the context of dose titration limitation and apparent reduced dosage activity, Anthera will initiate activities for an additional clinical study of Sollpura in patients with EPI due to Cystic Fibrosis, which Anthera expects will enable optimized dosing and dose titration. This study will provide investigators and patients the flexibility to adjust their Sollpura dose based upon malabsorption symptoms at any time during the study. Anthera believes that these modifications in the study design will allow patients to achieve the optimal level of fat absorption as measured by CFA.

The new study will begin in the first-quarter of 2017, and Anthera anticipates only a modest delay in the filing of the BLA around the first-quarter of 2018, as the new study will complete concurrently with the completion of required CMC activities.