Benzinga | Jun 14, 2021 07:06AM EDT

Landos Biopharma Announces Outcome Of End-Of-Phase 2 Meeting With FDA For Omilancor In Mild-To-Moderate Active Ulcerative Colitis; Co. And FDA Agreed On Key Elements Necessary For Approval

Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced Artificial Intelligence (A.I.) platform to discover and develop novel oral therapeutics for patients with autoimmune and inflammatory diseases, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (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 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, with 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.

"We are pleased with the results of our End-of-Phase 2 meeting with the FDA and are excited to be able to progress omilancor into Phase 3 development as a potentially improved treatment option for a broad population of patients with mild-to-moderate active UC worldwide," said Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Our Phase 2 results indicated omilancor was well-tolerated with strong efficacy signals, which we believe support its potential as a pre- and post-biologic broad-spectrum therapy for UC patients, and provided us with invaluable insights for the design of our Phase 3 PACIFY trials. We are appreciative of the support and guidance from the FDA and are working to initiate the Phase 3 global program in the U.S., Europe and Asia, to support regulatory approvals in the U.S., European and Asian markets."

The Phase 3 design was supported by nonclinical and clinical safety and efficacy data, including encouraging results from a Phase 2 study that evaluated omilancor in 198 patients with mild-to-moderate active UC and which demonstrated statistically significant immunological and biomarker results that mirror activation of the novel LANCL2 mechanism by omilancor in the gut. Phase 1 and Phase 2 clinical data demonstrated that omilancor was well tolerated at all doses evaluated, with no dose-limiting toxicities.