First Wave BioPharma Inc FWBI shares are trading higher after the company achieved its enrollment target for its adrulipase Phase 2 SPAN trial for exocrine pancreatic insufficiency in cystic fibrosis patients.
The Phase 2 multi-center trial is designed to investigate the safety, tolerability, and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study.
The primary efficacy endpoint is the coefficient of fat absorption, with secondary endpoints of stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption. Topline results from the study are anticipated by mid-2023.
The company says that two-thirds of patients have completed the study, and the final patients are being dosed.
The SPAN trial is an open-label study with 13 cystic fibrosis patients enrolled.
The trial design employs a dose titration strategy. Patients will be screened at baseline to ensure a coefficient of fat absorption of at least 80%.
Eligible patients will then be switched from their commercial enzyme product to adrulipase. Each patient will be started on a low dose of adrulipase.
If the patient is not clinically controlled, the patient will be switched to a medium dose, and if not controlled on this dose, the patient will be advanced to a high dose.
The titrations will be carried out over three weeks, after which a CFA will be obtained.
A post-treatment safety visit will be conducted one week after the treatment period.
Price Action: FWBI shares are up 107.6% at $2.37 on the last check Tuesday.
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