The Biocomplexity Institute of Virginia Tech congratulates Josep Bassaganya-Riera, Director of the Nutritional Immunology and Molecular Medicine Laboratory and founder of Landos Biopharma on the successful completion of the Phase 1 clinical trial of BT-11, a first-in-class, orally active, gut-restricted therapeutic with limited systemic exposure for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). The final Phase 1 data was released in San Francisco during the JP Morgan investment conference.

UC and CD are the two primary clinical manifestations of Inflammatory Bowel Disease (IBD), which is a group of chronic and disabling disorders that greatly impact a patient’s quality of life. UC and CD 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.

Landos’ lead clinical asset, BT-11, is a novel, oral, gut-restricted, small molecule targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the gastrointestinal tract for the treatment of Crohn’s and colitis. BT-11 has shown outstanding therapeutic efficacy in preclinical models of IBD, a benign safety profile without the concerns of systemic exposure, and has two open Investigational New Drug (INDs) for evaluation in UC and CD. BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract. 

The randomized, double-blind, placebo-controlled trial conducted in 70 healthy subjects to assess the safety of BT-11 found that BT-11 was well-tolerated and showed no dose-limiting toxicities. Among the subjects, the overall adverse events (AEs) profile observed was consistent when compared to AEs in the placebo cohort and no differences were observed between groups. The study tested levels of BT-11 ranging from 7 mg/kg up to 100 mg/kg and did not reach a maximum tolerated dose.

“The results of our Phase 1 study provide the first-in-human clinical data in support of BT-11 as a novel oral treatment for IBD. We are pleased to see that BT-11 was well-tolerated and safe in healthy volunteers,” said Bassaganya-Riera, Chairman and CEO of Landos. “Importantly, we are very encouraged by the reduction of fecal calprotectin in BT-11-treated subjects, which could represent an early anti-inflammatory signal, and supports the potential of BT-11 as an important advancement in the treatment of inflammatory bowel disease. These study results, along with extensive preclinical efficacy models of IBD, support the evaluation of BT-11 in Phase 2 proof-of-concept efficacy studies in UC and CD patients, which we plan to initiate this year.”

“These results are promising for IBD patients in need of a more convenient treatment for UC and CD,” said Jean-Frederic Colombel, M.D., a Landos Clinical Advisory Board member, world-renowned gastroenterologist and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “We continue to see an unmet clinical need for chronic oral therapies to treat UC and CD that can improve safety, tolerability and convenience.”

About Landos

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 www.landosbiopharma.com or contact info@landosbiopharma.com or follow them at @Landosbio.

Published by Tiffany Trent, January 15, 2019