TrialWatch: Landos Biopharma Automimmune Phase I Trial Shows Promising Results

Jan 11, 2019 | Autoimmune Disease, Inflammatory Bowel Disease, Positive Results

Landos Biopharma, Inc. is an emerging 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 novel, locally-acting small molecule targeting inflammatory bowel disease (IBD) that is expected to enter clinical testing for Crohn’s Disease in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases. Landos is headquartered in Blacksburg, VA. It has raised $10 million in VC funding.        

The randomized, double-blind, placebo-controlled trial was conducted in 70 healthy subjects to assess the safety of BT-11. It 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.”

This randomized, double-blind, placebo-controlled Phase 1 trial evaluated the safety and tolerability of BT-11 in five cohorts of single ascending and three cohorts of multiple ascending dose studies in 70 healthy subjects. The study tested levels of BT-11 ranging from 7 mg/kg up to 100 mg/kg. Within the subject group of the study, BT-11 was well-tolerated and showed no safety concerns or dose-limiting toxicities.


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