Landos Biopharma Stock Is Trading Higher On Initiating Early-Stage Study With Omilancor For Esophagus Inflammation - Landos Biopharma (NASDAQ:LABP)

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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