First Wave BioPharma Says Phase 2 SPAN Study Did Not Meet Primary Goal; Stock Tumbles

(RTTNews) - First Wave BioPharma, Inc., (FWBI) Thursday said Phase 2 SPAN study evaluating enhanced formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) did not meet its primary goal.

In the Phase 2 SPAN study, 13 patients were treated with an enteric microgranule delivery formulation of adrulipase.

Initial data from the study showed that the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the study did not meet the primary endpoint, which was the coefficient of fat absorption (CFA).

First Wave BioPharma said it is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in about eight weeks.

First Wave BioPharma is down more than 32% in pre-market trading at $0.9109. On Wednesday the stock closed at $1.34, down 9.46%. It has traded in the range of $1.1150 - $44.7300 in the last 52 weeks.