First Wave BioPharma, Inc. announced that it has entered into an agreement with Rho, a full-service contract research organization (CRO), for its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase. First Wave BioPharma is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). The Phase 2 clinical trial is expected to initiate prior to the close of 2022.
Under the agreement, Rho will manage the Phase 2 clinical trial of the microgranule drug delivery formulation of adrulipase. In vitro data suggest the formulation offers improved protection against the acidic pH in the stomach followed by rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit. Additionally, in vitro research indicates the enhanced formulation has the potential to significantly decrease the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill burden for current commercial pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, creating a substantial challenge for EPI patients.
“We are preparing to initiate the planned Phase 2 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 programs,” said James Sapirstein, President and CEO of First Wave BioPharma. “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 2 clinical trial, which we expect to initiate before year-end.”
“We are delighted to continue our work with First Wave BioPharma and are eager to use the expertise we’ve gained from managing prior clinical programs involving adrulipase,” said Dr. Jack Modell, Chief Medical Officer from Rho. “We look forward to being a valued partner to First Wave BioPharma in the management of the soon-to-be-initiated Phase 2 trial.”
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