First Wave signs up Rho for phase 2 trial of gastrointestinal drug

First Wave Biopharma has inked a deal for Rho to run a phase 2 trial of the biopharma’s treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.

First Wave’s adrulipase is an oral recombinant lipase enzyme that is designed to break up fat molecules in the digestive tract of EPI patients so the molecules can be absorbed as nutrients. According to the Cystic Fibrosis Foundation, more than 30,000 people in the U.S. suffer from EPI caused by cystic fibrosis, and the National Pancreas Foundation estimates about 90,000 patients in the country have EPI caused by chronic pancreatitis.

Rho has managed prior clinical programs involving adrulipase. The latest trial is expected to begin by the end of the year, First Wave said in an Oct. 31 press release. Financial terms weren’t disclosed.

“Research, including data recently presented at AAPS 2022, indicates the new adrulipase formulation should deliver the drug in the intended area of the gastrointestinal tract,” First Wave CEO James Sapirstein said in the release.

Just over a year ago, AzurRx acquired First Wave and took on its name in a cash-and-stock deal valued at up to $229 million.