First Wave BioPharma shares slide as study likely to miss goal

14 July 2023

Shares of First Wave BioPharma (Nasdaq: FWBI) closed down more than 32% at $0.90 on Thursday, after the company said a Phase II study of an enhanced formulation of its adrulipase drug candidate seems likely to have missed its primary efficacy endpoint.

The company received top-line results from the Phase II SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved. First Wave BioPharma is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.

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