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® 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
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.
About Ulcerative Colitis (UC)
About Landos Biopharma
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the “Company”), including statements about the Company’s strategy, clinical development and regulatory plans for its product candidates, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “anticipate”, “plan”, “expect”, “may”, “will”, “could”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other similar risks. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
Hannah Gendel (media)
Mobile Edge Compute: Quick and Smart
Cannabis Technology Supply Chain and Product Stacks
ITEXPO #TECHSUPERSHOW Expo Hall Open