First Wave BioPharma has completed patient screening in its ongoing Phase II SPAN clinical trial of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients.
To be conducted at three sites in the US, the multi-centre, open-label study intends to enrol 12 cystic fibrosis patients aged 18 years or above.
The study will investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study.
Coefficient of fat absorption (CFA) is the primary efficacy endpoint while coefficient of nitrogen absorption, signs and symptoms of malabsorption, and stool weight are the secondary endpoints of the study.
Topline results from the study are expected in July of this year.
The design of the trial employs a dose titration strategy. Patients with CFA of at least 80% are screened and then switched from their commercial enzyme product to adrulipase.
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Initial treatment for each patient will be a low dose of adrulipase and if not clinically controlled they will be switched to a medium dose.
Further, patients will be advanced to a high dose when not controlled on the medium dose.
The titrations will be carried out over a three-week period, after which a CFA is obtained which will be compared to the baseline CFAs in a descriptive manner.
The company intends to conduct a post-treatment safety visit, one week after completion of the treatment period.