By Chris Wack


First Wave BioPharma Inc. shares were up 16% to $3.26 one day after the company said the U.S. Food and Drug Administration reviewed its Investigational New Drug application and provided a "Study May Proceed" letter for a Phase 2a trial.

The trial is investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors.

FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties.

The company said the Phase 2a clinical trial is designed to determine the safety, tolerability, and preliminary efficacy of FW-ICI-AC in the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in advanced cancer patients. About 60 patients will be enrolled in the trial and divided into two arms.

One arm will receive FW-ICI-AC three times daily for two weeks, while the other arm will receive placebo three times daily for two weeks. Following treatment, each patient will enter a four-week evaluation period. The primary endpoint of the trial is safety and tolerability of FW-ICI-AC. Additional endpoints will measure early signals of efficacy, including resolution of the patient's diarrhea, sparing of steroids, and prevention of disease progression.

First Wave shares ended Tuesday's session up 3%.


Write to Chris Wack at


(END) Dow Jones Newswires

October 20, 2021 10:39 ET (14:39 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.