Benzinga | Jul 22, 2021 07:14AM EDT

Landos Biopharma's Phase 2 Data of Omilancor in Ulcerative Colitis Accepted for Oral Presentation at the United European Gastroenterology Week 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, Landos initiated clinical trial site feasibility studies for the planned global pivotal Phase 3 trial of omilancor in UC

BLACKSBURG, Va., July 22, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE(r) 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.

"We believe that omilancor, a novel, oral, gut-restricted therapeutic targeting the LANCL2 pathway, is positioned to transform the treatment paradigm for UC patients," said Dr. Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "We are incredibly honored to present at UEGW 2021 our Phase 2 omilancor clinical findings across key immunology biomarkers and results on histological remission suggesting durability of response, which we believe further validate and de-risk the LANCL2 mechanism of action (MOA). Overall, the data further affirms our plans for the global pivotal Phase 3 program of omilancor in UC patients targeting a broad label that could encompass nearly 90% of UC patients ranging from pre-biologic patients to those who fail biologics."

The presentation will focus on the mechanism-validating immunological data generated from the Phase 2 study in addition to the clinical remission, histological remission and early fecal calprotectin normalization results. Importantly, analysis of colonic biopsy tissue of patients collected at week 12 showed an increase of IL-10-producing cells and regulatory CD4+ T cells locally in the gastrointestinal tract with omilancor treatment, which was strongly correlated with clinical and histological remission. These results validate the immunological consequences of activation of the LANCL2 pathway in UC patients, and show promise for the prediction of long-term efficacy of omilancor in UC patients. Recent findings from the open-label extension also indicate long-term therapeutic effect, with nearly 90% of patients reaching remission thresholds in stool frequency and rectal bleeding when treated with omilancor for up to 66 weeks in total.

According to Global Data, in 2020 the UC market in the United States alone generated nearly $5.3 billion in prescription sales and is anticipated to grow at over 6.0% per annum over the coming years.

Title: Safety, Pharmacokinetics, and Immunological Effects of Omilancor (BT-11) in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Ulcerative Colitis

Session: IBD clinical trials III

Session Type Live abstract-based oral session

Date/Time: Monday, October 4, 2021 from 3:00 -- 4:00 P.M. EDT

Phase 2 Clinical Results Summary for Omilancor in Ulcerative Colitis

* Omilancor showed 55% lower IL-6 concentrations and 44% lower TNF concentrations after 12 weeks of treatment, consistent with increased levels of regulatory CD4+T cells and myeloid cells and increased IL-10 expression in remitters (p = 0.036)

* Omilancor exhibited statistically significant decreases in TNF-a expressing myeloid cells (p = 0.037) in the colonic mucosa and statistically significant normalization of fecal calprotectin levels (p = 0.048)

* Omilancor maintained low Mayo scores following 1 year of treatment, with nearly 90% of patients achieving remission thresholds in stool frequency and rectal bleeding after 36 weeks of open-label treatment

The oral presentation will be made available under the "Publications" section of the Company's website at www.landosbiopharma.com concurrent with the live presentation on October 4th.