Anthera Pharmaceuticals has started a Phase III trial (Solution) of Sollpura (liprotamase) to treat patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Solution is a study of oral liprotamase unit-matched therapy of non-porcine origin in people with CF.
Sollpura is a new, non-porcine pancreatic enzyme replacement therapy (PERT) that features a biotechnology derived formulation of cross-linked crystalline lipase, crystalline protease, and amorphous amylase with substrate specificity.
The trial is designed to evaluate the efficacy and safety of Sollpura, a microbial derived, biotech PERT, compared to an approved, porcine-derived, enteric-coated product.
The multicentre, randomised, open-label, assessor-blind, non-inferiority, active-comparator trial is intended to evaluate the non-inferiority of Sollpura compared with a commercially available PERT in a population enriched for PERT responders.
Primary efficacy endpoint of the trial will be comparative efficacy measured as the change in the co-efficient of fat absorption (CFA) at the end of therapy.
Approximately 130 patients with EPI will be enrolled in the trial at more than 50 clinical sites across the US and Europe.
Anthera Pharmaceuticals chief medical officer Dr Colin Hislop said: "The initiation of the Solution clinical study marks a critical milestone for Anthera.
"With its solubility, stability, and absence of bulky enteric coating, we believe Sollpura has the potential to significantly improve the lives of people with EPI."
Results from the trial are expected to support marketing approval for Sollpura as a treatment for exocrine pancreatic insufficiency.
According to the company, Sollpura is potentially the first soluble, stable and non-pig derived enzyme product to provide a solution to people with EPI, including young children and adults, who are either unable to swallow multiple pills or forced to use gastric tubes to maintain better nutritional health.
Purified enzymes in Sollpura show improved solubility and stability to be co-administered with several liquids and food products.
