First Wave BioPharma Shares Rise 16% After FDA Letter
October 20 2021 - 9:54AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
October 20, 2021 10:39 ET (14:39 GMT)
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