Permission to Launch Phase 2 Trial of EPI Treatment Sought by First Wave
Adrulipase is an oral enzyme being developed as a non-animal-derived therapy
First Wave BioPharma has asked the U.S. Food and Drug Administration (FDA) for permission to start a Phase 2 clinical trial that would test the company’s new formulation of adrulipase in people with cystic fibrosis (CF) who have exocrine pancreatic insufficiency.
Submitting the application “is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase,” said James Sapirstein, president and CEO of First Wave.
“If the FDA grants authorization in the next 30 days, we expect to start the study in early 2023 with topline data anticipated towards the end of the first half of 2023,” Sapirstein said in a company press release.
Exocrine pancreatic insufficiency, or EPI, occurs when the pancreas isn’t able to sufficiently release certain enzymes needed for digestion, particularly for breaking down fats. EPI commonly develops in people with CF due to mucus building up in the pancreas, which clogs the organ and prevents it from secreting enzymes. EPI also can develop due to chronic pancreatitis, where the pancreas is damaged by inflammation. The upcoming trial would evaluate adrulipase for EPI in both conditions.
The current standard of care for EPI is porcine pancreatic enzyme replacement therapy (PERT), wherein enzymes derived from pigs are administered to aid digestion.
Adrulipase is a fat-digesting enzyme (lipase) derived from yeast that First Wave is developing as a non-animal-derived therapy for EPI. It’s being designed to be administered orally.
The company recently developed a new optimized formulation of adrulipase wherein the enzyme is packed in structures called micro-granules. This allows it to safely traverse the acidic environment of the stomach and get to the small intestine, where the bulk of digestion takes place. Once in the small intestine, the enzyme is able to help break down fats.
“The new adrulipase formulation can deliver the drug in the intended area of the gastrointestinal tract, where it can provide the desired therapeutic effect,” Sapirstein said.
According to First Wave, the new formulation might allow patients to take fewer pills to get a therapeutic effect. The company said some patients on standard PERT may have to take dozens of pills per day, which can be burdensome.
“We look forward to investigating this potential in a Phase 2 clinical trial and the opportunity to one day provide therapeutic relief to patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis,” Sapirstein said.