BLACKSBURG, Va.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/Crohns?src=hash" target="_blank"gt;#Crohnslt;/agt;–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
Phase 1 results of BT-11, its orally-active, gut-restricted
investigational new drug (IND) for Crohn’s disease (CD) and ulcerative
colitis (UC), in the IBD
Journal published in association with the Crohn’s
& Colitis Foundation. The first-in-human, Phase 1 single
ascending dose (SAD) and 7-day multiple ascending dose (MAD) studies
showed that BT-11 treatment is well-tolerated with no dose-limiting
toxicities, and no detectable systemic immunosuppression up to daily
oral doses of 100 mg/kg.
“The results of our Phase 1, first-in-human clinical study showed that
the adverse event (AE) profile between placebo and BT-11 cohorts were
comparable, and verified gut-restricted activity with minimal BT-11
systemic absorption, ” said Dr.
Josep Bassaganya-Riera, Chairman and CEO of Landos. “These Phase
1 clinical results reinforce BT-11’s safety profile and show lower
concentrations of fecal calprotectin, a predictive biomarker of
therapeutic response and extended clinical remission in both UC and CD.
These results support our plans to advance the evaluation of BT-11 to
Phase 2 therapeutic efficacy studies in UC and CD patients.”
The publication,
Safety, tolerability, and pharmacokinetics profile
of BT-11, an oral, gut-restricted LANCL2 agonist investigational new
drug for IBD: A randomized,
double-blind, placebo-controlled Phase I clinical trial,
was authored by researchers at Landos; the Icahn School of Medicine at
Mount Sinai, NYC, NY; and Royal Adelaide Hospital, Adelaide, Australia.
In the study,
oral BT-11 was assessed for safety, tolerability and Pharmacokinetics in
70 normal healthy volunteers in a randomized, double-blind,
placebo-controlled trial. Subjects were randomized into five single
ascending dose cohorts (up to 100 mg/kg, p.o.) and three multiple
ascending dose cohorts (up to 100 mg/kg QD for seven days, p.o.). Safety
and tolerability were assessed by adverse event reporting, vital signs,
ECG, hematology and clinical chemistry. BT-11 did not increase total or
gastrointestinal AE rates relative to placebo, with no serious adverse
events (SAE) observed. Oral BT-11 dosing did not result in any
clinically significant findings by biochemistry, coagulation, ECG,
hematology, or urinalysis when compared to placebo.
Additional details from the study:
-
The study found that fecal concentrations of BT-11 were 6,000-fold
higher than maximum plasma concentrations. We believe this
gut-restriction in humans validates the local actions of BT-11
observed preclinically in animal models, in which plasma
concentrations of BT-11 were less than 0.1% of fecal concentrations. -
BT-11 did not induce any effect on vital signs, cardiovascular or
respiratory function, no systemic immune effects were observed.
Clinical laboratory results additionally support a lack of hepatic and
renal toxicities in the study. -
BT-11 did not result in a decrease in White Blood Cell count or other
hematology related parameters, which suggests that given its
gut-restricted activity, BT-11 may reduce or avoid systemic
immunosuppression. These initial results are consistent with findings from
nonclinical studies and suggest a lower risk for systemic
immunosuppression with BT-11 as opposed to systemic IBD drugs. -
Doses of 7-14 mg/kg in the form of a once daily tablet are expected to
be evaluated in Phase II studies in IBD patients for therapeutic
effect. The results of this Phase 1 study suggest a wide safety margin
(7- to 15-fold compared to clinical doses to be studied) in human
subjects. -
Fecal calprotectin is believed to be a predictive biomarker in IBD, is
a key diagnostic test for differentiating UC and CD from IBS. Over 99%
of IBD patients have elevated calprotectin and is predictive of
relapse. In this study, fecal calprotectin levels were lower in all
BT-11 treated groups when compared to placebo.
Landos will present these results at the 2019 Digestive
Disease Week® (DDW) in San Diego, CA. The poster “TU1754:
SAFETY AND TOLERABILITY OF BT-11, A GUT-RESTRICTED LANCL2 AGONIST, IN A
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I STUDY IN NORMAL
HEALTHY VOLUNTEERS” will be presented by Andrew Leber, PhD,
Scientific Director of Landos, in the IBD: Controlled Clinical Trials in
Humans session, Clinical Practice, Inflammatory Bowel Diseases track,
Tuesday, May 21, 2019 from 12:00 PM – 2:00 PM.
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 is designed to intercept IBD by decreasing the production of
inflammatory mediators and increasing anti-inflammatory markers within
the gastrointestinal tract. BT-11 has shown positive therapeutic
activity in preclinical models of inflammatory bowel disease (IBD), a
favorable safety profile, 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 will
initiate a Phase 2 clinical program for BT-11 for treatment of UC and CD
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.
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Contacts
Landos Biopharma:
Josep Bassaganya-Riera
540.218.1767
jbr@landosbiopharma.com
For Media Requests:
Sharon
Correia
LaVoieHealthScience
617.412.8779
scorreia@lavoiehealthscience.com