First Wave BioPharma has reported topline data from its Phase II SPAN clinical trial of an enteric microgranule delivery formulation of adrulipase capsule to treat exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients.
The trial assessed the efficacy, tolerability, and safety of the formulation in a titrated dose-escalation study of 13 subjects.
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Coefficient of fat absorption (CFA) is the primary efficacy endpoint while coefficient of nitrogen absorption (CNA), signs and symptoms of malabsorption and stool weight are secondary endpoints of the trial.
First Wave BioPharma president and CEO James Sapirstein said: “Preliminary data from the Phase II SPAN clinical trial indicate our enhanced microgranule delivery formulation of adrulipase was safe and well tolerated.
“We are in the process of analysing the dataset and anticipate having a topline review of the primary and secondary endpoints in the September timeframe.
“We would like to thank the patients who volunteered to participate in the study and the investigators and their staff at our three participating clinical trial sites for ensuring that the trial was fully enrolled and completed on time.”
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By GlobalDataFirst Wave BioPharma plans to meet with the US Food and Drug Administration (FDA) to review the data.
In the meeting, the company and the FDA will discuss the parameters for initiating a Phase III trial that could fulfil the requirements for a Biologics License Application (BLA).
Adrulipase is a recombinant lipase enzyme and can break up fat molecules in the digestive tract of patients.
