Landos Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune diseases, announced the publication of findings that further characterize the safety profile of BT-11, its orally-active, gut-restricted investigational new drug (IND) for Crohns disease (CD) and ulcerative colitis (UC), in the International Journal of Toxicology published in association with the American College of Toxicology. The definitive non-clinical toxicity studies evaluated general and specific toxicities that are common safety concerns for pharmaceuticals. The data collected indicates that BT-11 does not induce any form of general toxicity, targeted organ or other specific toxicities in rats and dogs treated in pivotal, 90-day repeat-dose toxicity studies.
The results of 90-day toxicity studies along with ongoing chronic toxicity studies continue to illustrate that BT-11 has a benign safety profile and shows an enormous potential as an oral therapeutic for IBD showing no safety concerns on target organ systems or genotoxicity, said Dr. Josep Bassaganya-Riera, Chairman and CEO of Landos. We are pleased that the findings from these IND-enabling studies were validated by the results of Phase 1 first-in-human clinical testing in 70 normal healthy volunteers showing no differences in adverse event profile between placebo and BT-11 groups. Together, these study results support the evaluation of BT-11 in Phase 2 therapeutic efficacy studies in UC and CD patients, which Landos has initiated. BT-11 has the potential to address the unmet clinical need for safer and more effective drugs and disrupt the $10 billion IBD therapeutics market.
The study, Non-clinical Toxicology and Toxicokinetic Profile of an Oral Lanthionine Synthetase C-Like 2 (LANCL2) Agonist, BT-11, was authored by researchers at Landos. These studies tested BT-11 under Good Laboratory Practice (GLP) conditions in 90-day, repeat dose studies that evaluated general toxicity as well as toxicokinetic (TK), metabolic, genotoxic, respiratory, cardiovascular, and central nervous system responses. These non-clinical studies show BT-11 to be a safe and well-tolerated oral therapeutic with potential as a potent, new immunometabolic drug for UC and CD, with no-observed adverse effect level (NOAEL) >1,000 mg/kg.
Details from the study:
- BT-11 did not cause any clinical signs of toxicity, biochemical or hematological changes, including no decrease in white blood cell counts, or macroscopic or microscopic changes to organs in 90-day repeat-dose toxicity studies in rats and dogs at any of the doses tested up to 1,000 mg/kg/d.
- Oral BT-11 resulted in low systemic exposure in both rats (area under the curve exposure from t=0 to t=8 hours [AUC0-8] of 216 h x ng/mL) and dogs (650 h x ng/mL) and rapid clearance with an average half-life of 3 hours.
- BT-11 did not induce changes in respiratory function, electrocardiogram parameters, or behavior with oral doses up to 1,000 mg/kg/d.
- There was no evidence of mutagenic or genotoxic potential for BT-11 up to tested limit doses using an Ames test, chromosomal aberration assay in human peripheral blood lymphocytes, or micronucleus assay in rats.
Landos lead clinical asset, BT-11, is a novel, oral, gut-restricted investigational new drug (IND) targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the gastrointestinal tract for the treatment of Crohns disease (CD) and ulcerative colitis (UC). BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory markers within the gastrointestinal tract. BT-11 has shown outstanding therapeutic efficacy in preclinical models of inflammatory bowel disease (IBD), a benign safety profile without the concerns of systemic exposure and has two open INDs for evaluation in UC and CD. The Company completed Phase 1 testing of BT-11 in 2018 and plans to initiate Phase 2 testing in 2019.
IBD represents a group of chronic and disabling disorders that greatly impacts a patients quality of life. The two primary clinical manifestations of IBD – Crohns disease (CD) and ulcerative colitis (UC) – afflict 3 million Americans and 5 million people worldwide, with nearly 25% growth in prevalence over the last five years. There is an unmet clinical need for safer, more effective medications for these diseases as currently marketed therapeutics have a number of drawbacks: they only benefit a small number of the overall population, lose response effectiveness, or cause high rates of serious side effects, including cancer, infection, and death.
About Landos Biopharma
Landos Biopharma, Inc. is a clinical-stage 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 first-in-class, oral therapeutic that acts locally in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD). The company has completed Phase 1 clinical testing and plans to initiate Phase 2 clinical testing of BT-11 for inflammatory bowel disease in 2019. Landos also has a robust pipeline of new compounds for other autoimmune diseases, several of which will advance to IND in 2019. Landos is headquartered in Blacksburg, VA. For more information, please visit www.landosbiopharma.com or contact [email protected] or follow us @Landosbio.
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