SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
|(State or Other Jurisdiction
|(Address of Principal Executive Offices)
(Registrant’s Telephone Number, Including Area Code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act.
Title of each class
Name of exchange
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On July 22, 2021, Landos Biopharma, Inc. (the “Company”) issued a press release to announce that Phase 2 data of Omilancor in Ulcerative Colitis was accepted for oral presentation at the United European Gastroenterology Week 2021. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
|Press Release, dated July 22, 2021.
|The cover page from Landos Biopharma, Inc.’s Form 8-K filed on July 22, 2021, formatted in Inline XBRL.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Landos Biopharma, Inc.
|Dated: July 22, 2021
|Chief Executive Officer
Landos Biopharmas 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 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
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-α 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 Companys website at www.landosbiopharma.com concurrent with the live presentation on October 4th.
About Ulcerative Colitis (UC)
UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patients life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics.
Discovered using Landos proprietary LANCE® Advanced A.I. platform, omilancor is a novel, oral, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway impacting the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation. Landos reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in patients with mild-to-moderately active UC. Additionally, Landos initiated a Phase 2 trial of omilancor in patients with Crohns disease in the first half of 2021 with topline results expected in the first half of 2022.
About Landos Biopharma
Landos Biopharma is a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced A.I. platform to discover and develop novel oral therapeutics for patients with autoimmune diseases. LANCE has discovered new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma has 17 active development programs targeting these novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel gut-restricted small molecule drug candidate for the treatment of ulcerative colitis, Crohns disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, gut-restricted small molecule drug candidate for the treatment of inflammatory bowel disease, that targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.
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 Companys strategy, clinical development and regulatory plans for its product candidates, the Companys 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 Companys 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 SECs 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 Companys views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Companys 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 Companys views as of any date subsequent to the date hereof.
Michael K. Levitan (investors)
Hannah Gendel (media)