Anthera starts Phase 3 study of Sollpura pancreatic enzyme replacement therapy

The SOLUTION clinical study is designed to evaluate the efficacy and safety of Sollpura, a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product.

It is aimed at evaluating Sollpura compared with a commercially available PERT in a population enriched for PERT responders.

The primary efficacy endpoint will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) at the end of therapy.

Anthera will enroll about 130 patients with exocrine pancreatic insufficiency in over 50 clinical sites across the US and Europe.

Results from the study are expected to support marketing approval for Sollpura as a treatment for exocrine pancreatic insufficiency.

Anthera Pharmaceuticals chief medical officer 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."

Anthera said Sollpura represents 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 for maintaining better nutritional health.

The purified enzymes in Sollpura show improved solubility and stability to be co-administered with several liquids and food products.

Sollpura is a novel, nonporcine PERT featuring a biotechnology-derived formulation of cross-linked crystalline lipase, crystalline protease, and amorphous amylase with substrate specificity.