BLACKSBURG, Va.—(BUSINESS WIRE)—Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune diseases, announced the publication of findings that further elucidate the regulatory arm of the novel mechanism of action for BT-11, its investigational new drug (IND) for Crohn’s disease and ulcerative colitis, in the Journal of Immunology. This study investigated the immunoregulatory mechanisms by which oral treatment with BT-11 provides protection from inflammatory bowel disease (IBD). The study concludes that BT-11 effectively induces and maintains lasting immune tolerance in the gastrointestinal tract through immunoregulatory mechanisms mediated by CD4+ regulatory T (Treg) cells.

“These results illustrate that BT-11’s novel, dual mechanism shows direct anti-inflammatory and pro-regulatory effects that represent a unique differentiator when compared to current therapeutics for autoimmune diseases as well as the majority of those in development,” said Dr. Josep Bassaganya-Riera, Chairman and CEO of Landos. “BT-11 represents a first-in-class, oral, gut-restricted, chronic therapeutic to treat ulcerative colitis and Crohn’s disease that can potentially improve safety, efficacy, tolerability and convenience thus affording an unprecedented opportunity to disrupt the $10 billion IBD therapeutics market and address the unmet clinical need for safer and more effective drugs.”

The study, Oral Treatment with BT-11 Ameliorates Inflammatory Bowel Disease by Enhancing Regulatory T Cell Responses in the Gut, was authored by researchers at Landos and aimed to validate the critical importance of regulatory CD4+ T cells for the therapeutic efficacy of BT-11 in IBD. The study further defined the cellular and molecular mechanisms of BT-11 in the colonic mucosa and found evidence that BT-11 establishes long-lasting effects on the maintenance and promotion of immune tolerance in the GI tract.

Details from the study:

  • BT-11 enhances CD25/STAT5 signaling to support the stable differentiation of regulatory CD4+ T cells with greater suppressive functionality that are resistant to effector-biased phenotypic plasticity, thereby contributing to a faster mucosal healing.
  • When tested in an in vivo, chronic model, the immune effects of BT-11 were retained after discontinuation of BT-11 treatments as measured by cellular composition and reduction in histological lesions, indicating lasting immunological tolerance.
  • BT-11-treated Tregs retain greater suppressive effects in the absence of IL-10 due to enhanced contact-mediated suppression in line with the observed natural Treg phenotype in vivo, revealing further details on how BT-11 regulates inflammation in the GI tract.
  • Depletion of Tregs reduces retention of tolerance after discontinuing BT-11 treatment displaying the critical role of Tregs for the efficacy of BT-11 in the induction and maintenance of immunological tolerance in IBD.

About BT-11
Landos’ lead clinical asset, BT-11, is a novel, oral, gut-restricted investigational new drug (IND) targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the gastrointestinal tract for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract. BT-11 has shown outstanding therapeutic efficacy in preclinical models of inflammatory bowel disease (IBD), a benign safety profile without the concerns of systemic exposure and has two open INDs for evaluation in UC and CD. The Company completed Phase 1 testing of BT-11 in 2018 and plans to initiate Phase 2 testing in 2019.

About IBD
IBD represents a group of chronic and disabling disorders that greatly impacts a patient’s quality of life. The two primary clinical manifestations of IBD – Crohn’s disease (CD) and ulcerative colitis (UC) – afflict 3 million Americans and 5 million people worldwide, with nearly 25% growth in prevalence over the last five years. There is an unmet clinical need for safer, more effective medications for these diseases as currently marketed therapeutics have a number of drawbacks: they only benefit a small number of the overall population, lose response effectiveness, or cause high rates of serious side effects, including cancer, infection, and death.

About Landos Biopharma
Landos Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a first-in-class, oral therapeutic that acts locally in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD). The company has completed Phase 1 clinical testing and plans to initiate Phase 2 clinical testing of BT-11 for inflammatory bowel disease in 2019. Landos also has a robust pipeline of new compounds for other autoimmune diseases, several of which will advance to IND in 2019. Landos is headquartered in Blacksburg, VA. For more information, please visit or contact or follow us @Landosbio.


Landos Biopharma:
Josep Bassaganya-Riera

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Sharon Correia
LaVoieHealth Science