Anthera Pharmaceuticals has completed the last patient visit in the primary treatment phase of a Phase 3 clinical trial evaluating Sollpura (lipromatase) for exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Two interim analyses conducted by an independent data monitoring committee appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network found no safety concerns, and allowed the study to continue as planned.
Top-line data of the Phase 3 RESULT trial (NCT03051490) should be available later this quarter, said the company, based in Hayward, California. The study enrolled 140 patients, aged 7 to 58 years.
“We are just weeks away from top-line data now that the final patient has completed the last treatment visit in the RESULT study,” Anthera President and CEO Craig Thompson said in a press release. “Sollpura is one step closer to potentially providing the first oral, non-porcine pancreatic enzyme replacement therapy (PERT). We look forward to sharing the top-line data once available.”
CF is the second most common cause of EPI, a condition that occurs when thick mucus in the pancreas blocks pancreatic enzymes from entering the small intestine. The lack of pancreatic enzymes prevents the digestive tract from completely digesting food — especially fats and proteins — leading to malnutrition.
Pancreatic enzyme replacement therapy (PERT) is based on pills containing a mixture of pancreatic enzymes, namely lipase, amylase and protease. These help digest fat, carbohydrates and proteins.
However, pancreatic enzyme supplements are extracted from pig pancreas glands, and no alternative to pig products exists yet.
The enzymes in Sollpura, a biotechnology product that eliminates the need for porcine-derived enzymes, are not absorbed into the bloodstream, and have been found to be very stable. Their design also reduces the amount of pills patients must take daily.
Based on the anticipated outcomes of the RESULT trial, Sollpura could become the first oral, non-porcine PERT that may reduce the size and number of pills for patients with EPI.