Landos Biopharma: FDA Meeting Clears Path for Omilancor Phase 3 Program
June 14 2021 - 7:45AM
Dow Jones News
By Michael Dabaie
Landos Biopharma Inc. said it had a successful outcome of an
end-of-Phase 2 meeting with the U.S. Food and Drug Administration
for omilancor, its lead candidate for mild-to-moderate active
ulcerative colitis.
Landos said it and the FDA agreed on key elements necessary for
regulatory approval, clearing a path for a Phase 3 program with
omilancor.
The program will include two Phase 3 clinical trials and
evaluate a single dose of omilancor, with primary objectives of
clinical remission at weeks 12 and 52, the company said.
Landos said it is working to finalize the details of the Phase 3
protocols based on feedback and guidance from the FDA.
Ulcerative colitis is a chronic, autoimmune, inflammatory bowel
disease that is estimated to affect more than 900,000 patients in
the U.S. and over 1 million patients throughout the rest of the
world, Landos said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 14, 2021 07:43 ET (11:43 GMT)
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