Landos Biopharma, Inc announced on 7/12/2018 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. “Despite current treatments, there remains an unmet clinical need for chronic therapies for UC and CD with improved safety and tolerability.”
BT-11 has demonstrated a 90% reduction of inflammation by acting locally in the gut mucosa in 4 validated mouse models of IBD at doses of 8 mg/kg/d. It has also demonstrated excellent human translation in in vitro human translational studies with cells from Crohn’s disease patients.
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.
In addition to BT-11, Landos has six other candidates in development. The other candidates are intended to treat a number of conditions including type 1 and type 2 diabetes and rheumatoid arthritis.