Landos Biopharma: FDA Meeting Clears Path for Omilancor Phase 3 Program

 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.

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