Results from Phase 2 adrulipase trial for EPI expected next month
13 participants have enrolled for SPAN study
Top-line results are expected next month for the SPAN clinical trial, a Phase 2 study testing First Wave BioPharma‘s new formulation of adrulipase to treat exocrine pancreatic insufficiency (EPI) in people with cystic fibrosis (CF).
The trial’s target enrollment has been reached, with 13 total participants signed on, the company announced. Two-thirds of the participants have already finished and the final participants are being dosed.
“We are very pleased to have reached the enrollment target in our Phase 2b SPAN study of adrulipase,” James Sapirstein, CEO of First Wave, said in a company press release. “The majority of patients in the study have completed dosing and the remaining patients are currently being dosed. We remain on track to report top-line data in July 2023.”
A feature of CF is the buildup of thick mucus in the organs. When this mucus blocks the release of digestive enzymes from the pancreas into the intestines, making it harder to digest certain foods types, most notably fats, EPI can result.
Testing adrulipase for cystic fibrosis-related EPI
The current standard care for EPI is pancreatic enzyme replacement therapy (PERT), which typically involves administering pig-derived versions of the missing enzymes. Adrulipase is a fat-digesting enzyme, or lipase, derived from yeast. The therapy’s new formulation is delivered using microgranules that help more of the enzyme get through the harsh acid of the stomach into the intestines where fat digestion takes place.
The SPAN trial (NCT05719311) enrolled adults with CF and EPI who had a coefficient of fat absorption (CFA) — a measure of the ability to digest fat — of at least 80% while on standard PERT treatments. A CFA of 80% is considered the minimum threshold to reach therapeutic benefits in EPI associated with CF.
In the trial, participants are switched from their current PERT medications to adrulipase for three weeks. Participants start on a low dose, but if EPI symptoms emerge, it may be increased. After three weeks, participants are switched back to their original PERT, with an additional follow-up visit for safety a week later.
The study’s main goals are to evaluate the safety of the experimental treatment and its effect on fat digestion, as measured by CFA. Other measures of digestive health will be assessed, including stool weight and nitrogen absorption, a measure of protein absorption.