Omilancor (BT-11), our lead product candidate, is a first-in-class, gut-restricted oral therapeutic candidate that targets LANCL2, a membrane receptor that has been shown to modulate immunological mechanisms that are associated with various autoimmune diseases such as ulcerative colitis (UC) and Crohn’s disease (CD).
In 2021, Landos announced final results from its Phase 2 proof-of-concept trial of omilancor in patients with mild-to-moderate UC. The results demonstrated that omilancor was gut-restricted and well tolerated, with a similar adverse event profile across placebo and omilancor groups. In addition, omilancor induced placebo-adjusted clinical remission rates of up to 11.5% at week 12, with normalization of biomarkers such as fecal calprotectin observed after two weeks of oral dosing. Based on clinical data to date, omilancor may address the main limitations of current therapies by providing a convenient once a day dosing that offers low systemic exposure, improved tolerability and no ties to toxicities. Following a positive outcome from an End-of-Phase 2 meeting with the U.S. FDA, Landos and the FDA agreed on key elements necessary for regulatory approval.
Additionally, Landos initiated a Phase 2 trial in May 2021 to evaluate proof-of-concept efficacy and safety of omilancor in patients affected by moderate-to-severe CD. Landos also expects to initiate a Phase 1b trial of omilancor in a third indication, Eosinophilic Esophagitis (EoE), in the first half of 2022.