The First Wave BioPharma Inc (NASDAQ: FWBI) stock soared 145.2% after announcing that it had reached the enrollment target for its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric micro granule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
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The clinical-stage biopharmaceutical company specialising in developing targeted, non-systemic therapies for gastrointestinal (GI) diseases has achieved this important milestone that will allow it to proceed with the clinical trial and potentially report its topline data in July 2023.
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The Phase 2 multi-centre clinical trial is designed to investigate the tolerability, safety and efficacy of an enteric micro granule delivery formulation for adrulipase in a titrated dose-escalation study involving about twelve (12) patients.
The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Topline results from the study are anticipated by mid-2023.
Today’s announcement follows other press releases about the clinical trial, including the completion of patient screening for its ongoing Phase 2 SPAN clinical trial on May 11, 2023, which was one of the last steps before today’s announcement.
Investors won’t have to wait long for the study results, given that we are in June and the results are expected by the end of July.
James Sapirstein, First Wave BioPharma’s CEO, commented: “We are very pleased to have reached the enrollment target in our Phase 2b SPAN study of adrulipase. The majority of patients in the study have completed dosing, and the remaining patients are currently being dosed. We remain on track to report topline data in July 2023”.
*This is not investment advice.
First Wave Bio (FWBI) stock price.
The First Wave Bio (FWBI) stock price soared 145.2% to trade at $2.80, from Monday’s closing price of $1.14.
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