Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on developing improved treatments for autoimmune diseases, announced today that the first healthy subjects have been dosed in a Phase 1 clinical study of BT-11, a first-in-class, orally-administered, molecule targeting the LANCL2 pathway. The Phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study intended to enroll up to 70 healthy volunteers to evaluate the safety and tolerability of BT-11.  BT-11 is in development for treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).

“We raised our Series A round in September 2017 to finance the completion of the IND-enabling studies and Phase 1 clinical testing. The FDA accepted Landos’ IND for BT-11 in June, and the dosing of the first subject cohort confirms that we have effectively executed that plan. Launching this trial marks a significant milestone for Landos and represents the next step in confirming the safety and effectiveness of BT-11 which has the potential to greatly impact the treatment options of millions of people afflicted by IBD around the world,” said Dr. Josep Bassaganya-Riera, Chairman and CEO of Landos and Director of the Biocomplexity Institute of Virginia Tech’s Nutritional Immunology and Molecular Medicine Laboratory (NIMML). “Despite current treatments, there remains an unmet clinical need for chronic therapies for UC and CD with improved safety and tolerability.”

“We are very excited to commence dosing on the first-in-human trial of BT-11. Current treatment options for IBD have a number of drawbacks as they only benefit a limited number of patients, lose response effectiveness, or cause unwanted side effects,” said Jean-Frederic Colombel, MD, a Landos Clinical Advisory Board member, world-renowned Gastroenterologist and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “An orally active therapeutic with local action in the GI tract and low systemic exposure such as BT-11 may represent a unique and promising approach to treating patients with safer, more convenient, and effective therapeutic alternatives to biologics, steroids, or surgeries.”

BT-11 is a first-in-class, orally-active, small molecule investigational candidate that activates the Lanthionine Synthetase C-Like 2 (LANCL2) pathway, targeting the gastrointestinal tract. Growing research suggests that the LANCL2 plays an important role in the immunoregulatory process. Based on the extensive preclinical and translational evidence, BT-11, by activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, creates a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory molecules within the site of inflammation.

The advanced computational platforms developed by NIMML have enabled the creation of high-resolution representations of the gastrointestinal tract. The integration of advanced computational efforts and drug development programs could accelerate the development of safe and more effective personalized chronic treatment options for autoimmune diseases.

About IBD

IBD represents a group of chronic and disabling disorders that greatly impact a patient’s quality of life. The two primary clinical manifestations of IBD - Crohn’s disease (CD) and ulcerative colitis (UC) - afflict 2 million North 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 BT-11

Landos’ lead product candidate BT-11 is a first-in-class, oral, locally-acting small molecule targeted to the gastrointestinal tract for treatment of inflammatory bowel disease. BT-11 has demonstrated safety and efficacy in multiple preclinical models, with safety and tolerability evaluation underway in a Phase 1 clinical study. BT-11 intercepts IBD by activating the LANCL2 pathway, decreasing the production of key inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract.

 

About Landos Biopharma, Inc.

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 novel, oral, locally-acting small molecule targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD) and is in Phase 1 clinical testing for Crohn’s disease and ulcerative colitis.  Landos also has a robust pipeline of compounds for other autoimmune diseases.  For more information, please visit www.landosbiopharma.com or contact  info@landosbiopharma.com or follow them on Twitter @Landosbio.

Published by Tiffany Trent, July 19, 2018