Anthera Pharmaceuticals Inc (NASDAQ:ANTH) reported that Sollpura failed to attain the non-inferiority margin of the CFA main endpoint in the RESULT Phase III clinical trial of exocrine pancreatic insufficiency due to cystic fibrosis. Craig Thompson, the CEO and President, expressed that they are highly disappointed by the outcomes of the RESULT trial. They would like to extend their deepest gratitude to study investigators, the subjects enrolled and their families, as well as the cystic fibrosis community for all the support they have offered in the clinical advancement of Sollpura.
Anthera Pharmaceuticals intends to assess the full data outcomes and will suspend further clinical advancement of Sollpura, counting the 20-Week Extension Period of the SIMPLICITY study in people ages 28 days to <7 years. This trial, RESULT was intended to evaluate Sollpura powder for oral solution. In addition, the company intends to assess all strategic alternatives so as to enhance shareholder value.
The design of the RESULT trial was based on the result of the previous Phase III SOLUTION trial and comprised a higher starting dose and aggressive dose optimizations depending on clinical symptoms and signs of malabsorption. In the RESULT trial, all subjects randomized to Sollpura obtained a starting dose that was around 25% higher as compared to their pre-study “PERT” dose and 59% of patients received additional dose adjustments, resulting in a mean Sollpura dose that was both considerably higher than the Pancreaze mean dose and more than the Sollpura dose in the earlier SOLUTION study.
Although a proportion of subjects randomized to Sollpura improved or maintained their CFA from baseline, an increased proportion of subjects noted a worsening. The mean treatment variation in CFA change from baseline came at 14.3%. However, the treatment variation in CNA change from baseline was within the non-inferiority margin of 15%.
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