Anthera Pharmaceuticals announced it will discontinue the development of Sollpura after the drug failed to meet the primary endpoint of a phase 3 trial.
Sollpura (liprotamase), an investigational pancreatic enzyme replacement therapy (PERT) for exocrine pancreatic insufficiency (EPI) due to cystic fibrosis, reportedly failed to achieve the non-inferiority margin of the coefficient of fat absorption (CFA) in the open-label RESULT study, which compared Sollpura with a commercially available PERT.
“We are greatly disappointed by the findings of the RESULT study,” Craig Thompson, president and CEO of Anthera said in a press release. “We would like to extend our deepest gratitude to the patients and their families, study investigators and the cystic fibrosis community for the support they have provided in the clinical development of Sollpura.”
The RESULT study was based on a previous phase 3 trial but included a higher starting dose and more aggressive dose optimizations. Investigators randomly assigned patients to Sollpura at a starting dose that was 25% higher than their pre-trial PERT level, and 59% of patients received further dose adjustments, according to the release.
Anthera reported that a higher proportion of patients who received Sollpura experienced a worsening in their CFA (14.3% change from baseline; with upper and lower 95% confidence intervals of –18.22 and –10.39). The drug did, however, achieve the secondary endpoint of coefficient of nitrogen absorption, the company noted.
Anthera has suspended further clinical development of Sollpura, including a 20-week extension of the RESULT study, and another phase 3 trial designed to assess a Sollpura powder for oral solution and a long-term safety study, according to the release.
Thompson is employed by Anthera.