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Landos Biopharma Doses First Patient in Global Trial

Tuesday, August 20, 2019  
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Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases announced dosing of the first patient in a Phase 2 study evaluating the safety and efficacy of BT-11 in patients with mild to moderate ulcerative colitis (UC). BT-11 is a novel, orally-administered, gut-restricted, first-in-class therapeutic in clinical development for UC and Crohn’s disease (CD).

“Dosing the first ulcerative colitis patients in this Phase 2 study is a crucial milestone for Landos. We believe the Phase 1 clinical results reinforced BT-11’s benign safety profile and showed a response to treatment based on lower concentrations of fecal calprotectin, which we believe is a predictive biomarker of therapeutic response and extended clinical remission in inflammatory bowel disease (IBD). We are excited to begin our first study in patients and to better understand the clinical utility of BT-11 in treating this important disease,” said Dr. Josep Bassaganya-Riera, Chairman of the Board. President, and CEO of Landos.

The global Phase 2 study will utilize a randomized, placebo-controlled, double-blind, parallel group, multicenter design to evaluate the safety, efficacy and tolerability of BT-11 compared to placebo in patients with mild to moderately-active UC. The study will enroll 195 UC patients with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe. Patients will be randomized to receive one of two doses of BT-11 (500 or 1,000 mg) or placebo for a 12-week induction phase followed by a maintenance phase. The study’s primary endpoint will assess the effect of treatment with once-daily doses of BT-11 tablets or placebo on clinical remission rate at week 12, as defined by total Mayo score  2 with all sub-scores 1.

“The medical community has long recognized the unmet need for safer, more convenient, and effective therapeutic alternatives to treating patients with ulcerative colitis,” 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. “The Phase 1 data are consistent with a benign safety profile without systemic immunosuppression and an initial efficacy signal based on lower fecal calprotectin levels. If BT-11 shows efficacy in Phase 2/3 clinical trials, it could ultimately provide long-term benefit for millions of people living with IBD."Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases announced dosing of the first patient in a Phase 2 study evaluating the safety and efficacy of BT-11 in patients with mild to moderate ulcerative colitis (UC). BT-11 is a novel, orally-administered, gut-restricted, first-in-class therapeutic in clinical development for UC and Crohn’s disease (CD).

“Dosing the first ulcerative colitis patients in this Phase 2 study is a crucial milestone for Landos. We believe the Phase 1 clinical results reinforced BT-11’s benign safety profile and showed a response to treatment based on lower concentrations of fecal calprotectin, which we believe is a predictive biomarker of therapeutic response and extended clinical remission in inflammatory bowel disease (IBD). We are excited to begin our first study in patients and to better understand the clinical utility of BT-11 in treating this important disease,” said Dr. Josep Bassaganya-Riera, Chairman of the Board. President, and CEO of Landos.

The global Phase 2 study will utilize a randomized, placebo-controlled, double-blind, parallel group, multicenter design to evaluate the safety, efficacy and tolerability of BT-11 compared to placebo in patients with mild to moderately-active UC. The study will enroll 195 UC patients with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe. Patients will be randomized to receive one of two doses of BT-11 (500 or 1,000 mg) or placebo for a 12-week induction phase followed by a maintenance phase. The study’s primary endpoint will assess the effect of treatment with once-daily doses of BT-11 tablets or placebo on clinical remission rate at week 12, as defined by total Mayo score ≤ 2 with all sub-scores ≤ 1.

“The medical community has long recognized the unmet need for safer, more convenient, and effective therapeutic alternatives to treating patients with ulcerative colitis,” 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. “The Phase 1 data are consistent with a benign safety profile without systemic immunosuppression and an initial efficacy signal based on lower fecal calprotectin levels. If BT-11 shows efficacy in Phase 2/3 clinical trials, it could ultimately provide long-term benefit for millions of people living with IBD."

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