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Toxicology Experiments Demonstrate that BT-11 has a Benign Safety Profile

April 15 2017

BLACKSBURG, VA, April 15, 2017 – Landos Biopharma, Inc. (LANDOS) lead oral therapeutic for inflammatory bowel disease (IBD)—BT-11—has demonstrated an outstanding therapeutic efficacy in 4 validated mouse models of IBD at doses as low as 8 mg/kg/day in addition to a benign safety profile at doses of 80 to 500 mg/kg and up to the limit dose of 1,000 mg/kg. These safety results, which were recently published in the International Journal of Toxicology, demonstrate that BT-11 is well tolerated in rats and holds great promise as an orally active, anti-inflammatory therapeutic for IBD.

“As a toxicologist with over 30 years of experience, I am confident that orally administered BT-11 is safe,” says Virginia-Maryland Regional College of Veterinary Medicine’s toxicologist Marion Ehrich, a former president of the Society of Toxicology, who led the Virginia Tech team in these safety studies and is the corresponding author on the paper. “Our data suggest that BT-11’s chemical properties allow limited systemic exposure after oral administration and that most of the compound reaches the lower gastrointestinal tract where it exerts its efficacy in IBD.”

LANDOS is advancing BT-11—an orally active, locally acting small molecule therapeutic that binds to Lanthionine Synthetase C-like 2 (LANCL2) and exerts potent anti-inflammatory effects in gut—towards investigational new drug (IND) filing plus Phase I and IIa human clinical testing in 2018.

“IBD, a widespread and debilitating disease, afflicts 4 million people worldwide and occurs when the immune system mistakenly destroys healthy gut tissue,” says LANDOS President and CEO Josep-Bassaganya-Riera. “LANDOS is working to fill an unmet clinical need for safer, more effective oral therapeutics for autoimmune diseases. Our program lead for IBD, BT-11, has the potential to become a first-in-class oral therapeutic that outperforms current IBD medications and INDs without the increased risk for infection, cancer, and death of standard-of-care medications.”

About LANDOS – Accelerated Path to Cures

Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of innovative first-in-class, oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, locally acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases.

Landos is headquartered in Blacksburg, Virginia. For more information, please visit or contact

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