Landos Biopharma Initiates Phase 1 Clinical Trial of BT-11, an Oral LANCL2 Agonist for Treatment of IBD


BLACKSBURG, Va.–()–Landos
Biopharma, Inc.
, a clinical-stage biopharmaceutical company focused
on developing improved treatments for autoimmune diseases, announced
today that the first healthy subjects have been dosed in a Phase 1
clinical study of BT-11, a first-in-class, orally-administered, molecule
targeting the LANCL2 pathway. The Phase 1 study is a randomized,
double-blind, placebo-controlled, single and multiple ascending dose
study intended to enroll up to 70 healthy volunteers to evaluate the
safety and tolerability of BT-11. BT-11 is in development for treatment
of inflammatory bowel disease (IBD), including ulcerative colitis (UC)
and Crohn’s disease (CD).

“We raised our Series A round in September 2017 to finance the
completion of the IND-enabling studies and Phase 1 clinical testing. The
FDA accepted Landos’ IND for BT-11 in June, and the dosing of the first
subject cohort confirms that we have effectively executed that plan.
Launching this trial marks a significant milestone for Landos and
represents the next step in confirming the safety and effectiveness of
BT-11 which has the potential to greatly impact the treatment options of
millions of people afflicted by IBD around the world,” said Dr.
Josep Bassaganya-Riera
, Chairman and CEO of Landos. “Despite current
treatments, there remains an unmet clinical need for chronic therapies
for UC and CD with improved safety and tolerability.”

“We are very excited to commence dosing on the first-in-human trial of
BT-11. Current treatment options for IBD have a number of drawbacks as
they only benefit a limited number of patients, lose response
effectiveness, or cause unwanted side effects,” 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. “An orally
active therapeutic with local action in the GI tract and low systemic
exposure such as BT-11 may represent a unique and promising approach to
treating patients with safer, more convenient, and effective therapeutic
alternatives to biologics, steroids, or surgeries.”

BT-11 is a first-in-class, orally-active, small molecule investigational
candidate that activates the Lanthionine Synthetase C-Like 2 (LANCL2)
pathway, targeting the gastrointestinal tract. Growing research suggests
that the LANCL2 plays an important role in the immunoregulatory process.
Based on the extensive preclinical
and translational evidence
, BT-11, by activating the LANCL2 pathway
and modulating the interactions between immunological and metabolic
signals in immune cells, creates a favorable regulatory microenvironment
in the gut, decreasing the production of key inflammatory mediators and
increasing anti-inflammatory molecules within the site of inflammation.

About IBD

IBD represents a group of chronic and disabling disorders that greatly
impact a patient’s quality of life. The two primary clinical
manifestations of IBD – Crohn’s disease (CD) and ulcerative colitis (UC)
– afflict 2 million North 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 BT-11

Landos’ lead product candidate BT-11 is a first-in-class, oral,
locally-acting small molecule targeted to the gastrointestinal tract for
treatment of inflammatory bowel disease. BT-11 has demonstrated safety
and efficacy in multiple preclinical models, with safety and
tolerability evaluation underway in a Phase 1 clinical study. BT-11
intercepts IBD by activating the LANCL2 pathway, decreasing the
production of key inflammatory mediators and increasing
anti-inflammatory molecules within the gastrointestinal tract.

About Landos Biopharma, Inc.

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 novel, oral, locally-acting small molecule
targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the
gastrointestinal tract for treatment of inflammatory bowel disease (IBD)
and is in Phase 1 clinical testing for Crohn’s disease and ulcerative
colitis. Landos also has a robust pipeline of compounds for other
autoimmune diseases. For more information, please visit www.landosbiopharma.com
or contact info@landosbiopharma.com
or follow us @Landosbio.



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