Why Are First Wave BioPharma Shares Tanking Today

First Wave BioPharma Inc FWBI shares are trading lower after the company received topline results from its Phase 2 SPAN trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency in cystic fibrosis patients. 

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.

The Phase 2 SPAN clinical trial was designed to investigate the safety, tolerability, and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving 13 patients. 

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.

Based on the initial safety and efficacy results, First Wave BioPharma plans to pursue an End-of-Phase 2 meeting with the FDA to review the data and discuss the parameters for a registrational Phase 3 clinical trial that would satisfy the requirements for a Biologics License Application. 

First Wave BioPharma anticipates conducting the End-of-Phase 2 meeting in the fourth quarter of 2023.

Price Action: FWBI shares are down 36.60% at $0.85 on the last check Thursday.