- The FDA has signed off Landos Biopharma's LABP Investigational New Drug application for omilancor (BT-11) for the treatment of Eosinophilic Esophagitis (EoE).
- Landos expects to initiate patient dosing in the first half of 2022. The 36-subject Phase 1b study is designed to evaluate the safety and pharmacokinetics of omilancor.
- Patients will be randomized in a 1:1:1 ratio to receive either omilancor 500 mg twice daily, omilancor 1000 mg once daily, or placebo for 12 weeks. Each of the treatment arms will include 12 subjects.
- The primary safety endpoint will measure the frequency and severity of adverse events and changes in clinical chemistry and hematology from baseline.
- The secondary endpoint is a pharmacokinetic analysis of omilancor plasma levels at various time intervals post-dosing, in addition to evaluating the mean concentration of omilancor in esophageal biopsy tissue after 12 weeks of dosing.
- Omilancor is an orally active, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-like 2 pathway impacting the gastrointestinal tract. LANCL2 plays a vital role in the immunoregulatory process.
- The Company reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a Phase 3 trial in the second half of 2021.
- Additionally, Landos plans to initiate a Phase 2 trial of omilancor in patients with Crohn's disease in the first half of this year.
- Price Action: LABP shares are trading 6.4% higher at $9.85 on the last check Tuesday.
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