Landos Biopharma, Inc. (NASDAQ: LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE® Advanced A.I. platform to develop novel oral therapeutics for patients with autoimmune diseases, today announced that data from the Phase 2 clinical trial of omilancor (BT-11-201) in ulcerative colitis (UC) has been accepted for oral presentation at the upcoming United European Gastroenterology Week (UEGW) 2021. The meeting will be held virtually from October 3-5, 2021.
Omilancor shows efficacy and tolerability as a potential once-daily, oral, gut-restricted therapy for mild-to-moderate UC patients
Following the recent positive End-of-Phase 2 meeting with the FDA, VTCRC based company Landos initiated clinical trial site feasibility studies for the planned global pivotal Phase 3 trial of omilancor in UC.
About Landos:
Landos Biopharma is a clinical stage biopharmaceutical company focused on the development of first-in-class, oral therapeutics for patients with autoimmune diseases. The Company’s mission is to create safer and more effective treatments that address the therapeutic gap in the current treatment paradigm.
Landos was established as an incredibly productive research engine, with a current portfolio of two novel targets anchoring libraries of immunometabolic modulation pathways, including four potentially first-in-class, once-daily, oral therapies targeting eight indications in the immunology space, including our clinical stage program NX-13 for Ulcerative Colitis (UC).
Our lead product candidate, NX-13, targets the NLRX1 pathway, a mitochondrial-associated regulatory NOD-like receptor. NX-13 is orally-active and gut-selective, allowing target engagement within the GI tract.
In August 2022, the Company reported positive top-line results from a NX-13 Phase 1b trial, demonstrating a favorable safety and tolerability profile in UC patients across a range of once-daily doses. Results also indicate promising early signals of clinical improvement as soon as two weeks in patients’ symptoms and four weeks by endoscopy in exploratory endpoints.
We are currently focused on advancing the clinical development of NX-13 in UC. In April 2023, we initiated the NEXUS Phase 2 proof-of-concept trial to evaluate the safety, efficacy and pharmacokinetics in patients with moderate to severe UC. The Company expects to report topline results by the fourth quarter of 2024.