Anthera shares plunge as company drops failed CF drug
- Anthera Pharmaceuticals Inc. has dropped all clinical development of its late stage cystic fibrosis drug, Sollpura, as it failed to meet its Phase 3 primary endpoint. The company's shares crashed down over 80% on the news.
- Sollpura did not meet the non-inferiority margin of the coefficient of fat absorption in the RESULT study, which compared Sollpura with Johnson & Johnson's Pancreaze (pancrelipase) in exocrine pancreatic insufficiency in cystic fibrosis. It did, however, meet the secondary endpoint of coefficient of nitrogen absorption, but this was not sufficient to continue studies.
- Anthera will continue to assess the data, and "plans to evaluate all strategic alternatives in order to maximize shareholder value."
Most patients with cystic fibrosis not only have respiratory problems, they also need to take enzymes before eating to treat pancreatic insufficiency. Anthera touted Sollpura (liprotamase), which contains biotechnology-derived lipase, protease and amylase, as the first soluble, stable and non-pig derived pancreatic enzyme replacement therapy (PERT). It also had potential to cut down on the number of oral capsules dosed per day compared with existing therapy.
However, after the data from the RESULT study, Anthera has suspended all further clinical development, which included the 20-week extension of RESULT, the SIMPLICITY study of Sollpura powder for oral solution in patients ages 28 days to less than 7 years old, and the EASY long-term safety study.
The only drug now remaining in Anthera's pipeline, according to the company's website, is blisibimod, a BAFF antagonist. Currently in development for the treatment of IgA nephropathy, blisibimod has completed a Phase 2 trial known as BRIGHT-SE. An interim analysis found a consistent slowing of proteinuria progression.
Blisibimod has also run into challenges, knocking a third off the company's share value back in November 2016 when it failed to hit its primary endpoint in a Phase 3 trial in systemic lupus erythematosus.
AzurRx BioPharma, Inc. is one of only a few companies looking at recombinant approaches to exocrine pancreatic insufficiency, with its lead candidate MS1819. Currently in a Phase 2a trial in chronic pancreatitis with AzurRx and partner Laboratoires Mayoly Spindler, SAS, MS1819 also has potential in cystic fibrosis.
- Anthera Pharmaceuticals Inc. Press release
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