Phase 1 Trial of Investigational BT-11 Begins Dosing First Volunteers, Landos Announces

Phase 1 Trial of Investigational BT-11 Begins Dosing First Volunteers, Landos Announces
A Phase 1 clinical trial testing Landos Biopharma’s investigational therapy BT-11 for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), has begun dosing healthy volunteers. Landos plans to enroll up to 70 healthy participants in the randomized, double-blind, placebo-controlled Phase 1 trial. They will be assigned to single and multiple ascending doses of BT-11, or a placebo control group, to assess the safety and tolerability of BT-11. “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,” Josep Bassaganya-Riera, chairman and CEO of Landos, said in a press release. “Despite current treatments, there remains an unmet clinical need for chronic therapies for UC and CD with improved safety and tolerability." BT-11 is a small molecule, given orally, that binds to a receptor, called LANCL2, leading to a potent anti-inflammatory response. Preclinical studies of BT-11, which acts locally in the gut mucosa, have shown that it reduces inflammation in the gut by 90%. The therapy has been validated in four different mouse models of IBD, where it outperformed other more expensive IBD therapies, including anti-TNF antibodies, aminosalicylate medicines known as 5-ASA, and even Celgene’s investigational GED-0301, wh
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