Landos Biopharma Shares Final Safety Results from Phase 1 Study of BT-11 in Healthy Volunteers
Wednesday, January 9, 2019
Landos Biopharma, Inc., an emerging clinical-stage, biopharmaceutical company focused on developing improved treatments for autoimmune diseases, today announces final results from the Phase 1 study of BT-11, a first-in-class, orally active, gut-restricted therapeutic for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD).
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 Dr. Josep 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, 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. “We continue to see an unmet clinical need for chronic oral therapies to treat UC and CD that can improve safety, tolerability and convenience.”