Accueil / Communiqués / Landos Biopharma Announces Publication of Results from Non-clinical Toxicity Studies Further Characterizing the Safety Profile of BT-11

Landos Biopharma Announces Publication of Results from Non-clinical Toxicity Studies Further Characterizing the Safety Profile of BT-11

Tuesday, March 5th 2019 at 12:00pm UTC

BLACKSBURG, Va.–(BUSINESS WIRE)– 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 Crohn’s
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.

About BT-11

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 Crohn’s 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.

About IBD

IBD represents a group of chronic and disabling disorders that greatly
impacts a patient’s quality of life. The two primary clinical
manifestations of IBD – Crohn’s 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 info@landosbiopharma.com or follow us @Landosbio.

Contacts

Company:
Landos Biopharma:
Josep Bassaganya-Riera
540.218.1767
jbr@landosbiopharma.com

For Media Requests:
Sharon
Correia
LaVoieHealth Science
617.412.8779
scorreia@lavoiehealthscience.com

Source: Landos Biopharma, Inc.


Voir aussi

Innovations in Artificial Intelligence, Blockchain, Quantum Computing, Robots, and Catalysts, 2019 Study – ResearchAndMarkets.com

Friday, March 22nd 2019 at 3:01pm UTC DUBLIN–(BUSINESS WIRE)– The « Innovations in Artificial Intelligence, Blockchain, …