The Phase II clinical trial will assess adrulipase as a treatment for exocrine pancreatic insufficiency. Credit: Diane Serik on Unsplash.

First Wave BioPharma has signed an agreement with full-service contract research organisation (CRO) Rho to manage its Phase II clinical trial of the enhanced adrulipase formulation.

The company is developing adrulipase, a recombinant lipase enzyme, to treat exocrine pancreatic insufficiency (EPI), which is related to cystic fibrosis (CF) and chronic pancreatitis (CP).

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The Phase II clinical trial is anticipated to begin before the end of this year.

Under the deal terms, Rho will be responsible for managing the Phase II clinical trial of the enhanced enteric microgranule drug delivery formulation of adrulipase.

As per in vitro data, the new formulation of the drug provides enhanced protection against the acidic pH in the stomach after the quick release of adrulipase in the small intestine.

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In the small intestine, the drug will mix with food and provide its treatment benefit.

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The in vitro research also suggests that the enhanced adrulipase formulation can significantly reduce pills a patient would require to take for the desired treatment effect.

First Wave BioPharma president and CEO James Sapirstein said: “We are preparing to initiate the planned Phase II trial of our new microgranule delivery formulation for adrulipase and are pleased to have Rho as our CRO partner given the company’s proven expertise and experience managing our prior adrulipase clinical programmes.

“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.

“We are eager to evaluate the potential of our new formulation in the proof-of-concept Phase II clinical trial, which we expect to initiate before year-end.”