Anthera Pharmaceuticals has received news that could help it accelerate patient enrollment in a Phase 3 clinical trial of Sollpura (liprotamase) as a treatment for a digestive disorder known as cystic fibrosis-triggered exocrine pancreatic insufficiency.
The news is that a key Cystic Fibrosis Foundation committee approved the company’s trial design. The sign-off from the foundation’s Therapeutics Development Network Protocol Review Committee could lead to additional medical facilities taking part in the trial. And more facilities could mean stepped-up patient recruitment.
Depending on the speed of patient enrollment, results of the study are expected by year’s end or in early 2018, the company said.
Exocrine pancreatic insufficiency, a common feature of CF, makes it more difficult for a person to digest food. It stems from the thick mucus associated with cystic fibrosis blocking the discharge of enzymes the pancreas creates to facilitate digestion.
Most PERTs are derived from pigs. Sollupura is not, which means it overcomes risks associated with obtaining enzymes from the animals. Those risks include viral contamination and limited supply.
The Phase 3 RESULT clinical trial (NCT03051490) that Anthera has just started will build on results of the Phase 3 SOLUTION trial (NCT02279498). SOLUTION demonstrated that Sollpura was as effective at treating exocrine pancreatic insufficiency as Pancreaze (pancrelipase), a pig-derived PERT.
A key finding of the SOLUTION trial was that both Sollpura and Pancreaze maintained patients’ height and weight, an indication their bodies were getting enough nutrients.
The RESULT trial will further assess Sollpura capsules’ ability to overcome CF patients’ exocrine pancreatic insufficiency, compared with Pancreaze. Researchers will adjust doses individually to try to achieve the best results.
“We are very pleased to leverage the CFF TDN [Cystic Fibrosis Foundation] clinical trial network and are excited by the progress made with the implementation of the RESULT study,” William Shanahan, chief medical officer of Anthera Pharmaceuticals, said in a press release.
Researchers are hoping to enroll 150 adults and children for the RESULT trial in the United States, Europe and Israel.