LABP - Landos Biopharma posts positive outcome from omilancor End-of-Phase 2 FDA meeting

Landos Biopharma (LABP) announces the successful outcome of an End-of-Phase 2 ((EOP2)) meeting with the U.S. FDA for omilancor, its lead candidate in late-stage clinical development for the treatment of mild-to-moderate active ulcerative colitis ((UC)) patients.Landos and the FDA agreed on key elements necessary for regulatory approval, clearing a path forward for a global pivotal Phase 3 program with omilancor in patients with mild-to-moderate active UC, the company said.The global pivotal PACIFY program will include two global pivotal Phase 3 clinical trials (PACIFY I and PACIFY II) and evaluate a single dose of omilancor versus placebo.The trials will look at primary endpoints of clinical remission at weeks 12 and 52 to support label claims of induction and maintenance of clinical remission measured using the 3-component Mayo score.Landos is working to finalize the details of the Phase 3 protocols based on feedback and guidance from the FDA.Shares of the company were

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Landos Biopharma posts positive outcome from omilancor End-of-Phase 2 FDA meeting