First Wave BioPharma announces phase 2 trial

pharmafile | January 31, 2023 | News story | Research and Development  

Clinical-stage biopharmaceutical company, First Wave BioPharma, has announced that it is planning to begin its phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase to treat exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients.

The phase 2 SPAN trial intends to assess the safety, tolerability and efficacy of the drug in a titrated dose-escalation study, involving an estimated 12 patients. The primary efficacy endpoint considers the coefficient of fat absorption (CFA), while secondary endpoints include stool weight, symptoms of malabsorption and coefficient of nitrogen absorption (CNA).

Patient screening for this trial is expected to begin in February this year, with data expected by the middle of 2023. The phase 2 trial will include three clinical trial sites throughout the US.

James Sapirstein, president and CEO of First Wave BioPharma, commented: “We are very pleased to announce the initiation of the phase 2 clinical trial investigating our new formulation of adrulipase as a potential treatment for EPI associated with cystic fibrosis and chronic pancreatitis. Preclinical research has demonstrated the new adrulipase formulation is able to deliver the drug in the intended area of the gastrointestinal tract where it can provide the desired therapeutic effect. This phase 2 clinical trial is designed to test that capability as a key step in our goal to provide patients with a more effective and convenient therapeutic option for EPI associated with cystic fibrosis and chronic pancreatitis.”


Betsy Goodfellow

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