Sollpura fails RESULT Phase III study for exocrine pancreatic insufficiency .- Anthera Pharma.
Anthera Pharmaceuticals, Inc. announced hat Sollpura did not meet the non-inferiority margin of the CFA primary endpoint in the RESULT Phase III clinical study of exocrine pancreatic insufficiency (�EPI�) due to cystic fibrosis. The design of the RESULT study was based on the outcome of the previous Phase III SOLUTION study and included a higher starting dose and more aggressive dose optimizations based on clinical signs and symptoms of malabsorption.
In the RESULT study, all patients randomized to Sollpura received a starting dose that was approximately 25% higher than their pre-study porcine pancreatic enzyme replacement therapy (�PERT�) dose and 59% of subjects received further dose adjustments, yielding a mean Sollpura dose (8,673 [range 2,925 � 14,941 lipase units/kg/day]) that was both substantially higher than the comparator Pancreaze mean dose (6527 [range 2358 - 10253 units/kg/day]) and higher than the Sollpura dose in the previous SOLUTION study (mean dose of 7,286 [range 4478 - 10000 units/kg/day]). Although a proportion of patients randomized to Sollpura maintained or improved their CFA from baseline, a higher proportion of patients experienced a worsening.
The mean treatment difference in CFA change from baseline was 14.3%, with upper and lower 95% confidence intervals of -18.22 and -10.39. In contrast, the treatment difference in CNA change from baseline (-1.53%) was well within the 15% non-inferiority margin. In comparison to the earlier SOLUTION study, the presence or absence of concomitant gastric acid suppressants had no meaningful effect on CFA (mean changes from baseline in CFA of -15.06% and -16.58%, respectively).
Anthera Pharmaceuticals, Inc. plans to evaluate the full data outputs and will suspend further clinical development of Sollpura, including the 20-Week Extension Period of RESULT, the SIMPLICITY study in patients ages 28 days to <7 years which was designed to assess sollpura powder for oral solution, and the easy study which was designed to follow the long-term safety of patients on sollpura.>
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