Anthera Pharmaceuticals has announced that Sollpura, a novel, non-porcine pancreatic enzyme replacement therapy, did not achieve the primary endpoint of the coefficient of fat absorption (CFA), however it did achieve the secondary endpoint of coefficient of nitrogen absorption (CNA) in the Phase 3 RESULT trial.
A total of 140 patients with exocrine pancreatic insufficiency due to cystic fibrosis were enrolled in the study and were randomized to receive Sollpura or the active-comparator, Pancreaze (Janssen). Those randomized to the Sollpura group received an approximately 25% higher starting dose (8,673 [range 2,925–14,941 lipase units/kg/day]) than their pre-study porcine pancreatic enzyme replacement therapy (PERT) dose. The mean Pancreaze dose was 6527 (range 2358–10253 units/kg/day).
Results showed 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, however the treatment difference in CNA change from baseline (-1.53%) was found to be well within the 15% non-inferiority margin.
“We are greatly disappointed by the findings of the RESULT study,” said Craig Thompson, President & CEO of Anthera. The Company will now suspend further clinical development of Sollpura. This includes a planned 20 week extension of RESULT, and also the EASY trial, which was planned to evaluate the long-term safety of Sollpura.
For more information call 1-510-856-5600 or visit Anthera.com.