Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases and Sanyal Biotechnology Inc,
a contract research organization built to serve the needs of
clients seeking preclinical research into liver disease and
metabolic syndrome, showed data to assess the effects of multiple
doses of larazotide on various markers of non-alcoholic
steatohepatitis (NASH). The companies also announced a
proprietary methodology utilizing a modified competition ELISA
enabling serial serum dextran measurements in small volumes of
serum to measure gut integrity. These data were reported in a
poster presentation at The Liver Meeting® 2018, the annual meeting
of the American Association for the Study of Liver Diseases
(AASLD), in San Francisco. Researchers sought to gauge the
effects of larazotide on gut integrity, using this highly specific
technique measuring dextran absorption. Western diet-fed
DIAMONDTM animals dosed with larazotide (low-dose gavage) had
significantly less intestinal permeability via dextran serum
measurements at 16 weeks when compared to negative control, vehicle
gavage or pioglitazone, a known NASH positive control which
has been used in multiple animal models and clinical trials (p =
0.049 and p = 0.04, respectively; n = 8 per arm).
Furthermore, pair-wise analysis showed that the administration of
larazotide over time was able to maintain gut integrity at close to
baseline levels, in effect preventing the barrier from
deteriorating. Agents which may prevent this “leaky” barrier
from worsening through the progression of NASH are thought to
provide a potential advantage in treating non-alcoholic fatty liver
disease (NAFLD) and NASH. Innovate intends to submit more
complete NASH preclinical results for publication at a major
upcoming conference and plans to commence a clinical trial for NASH
in 2019.
Dr. Arun Sanyal, Professor and Chair, Division of
Gastroenterology, Hepatology and Nutrition at the Virginia
Commonwealth University (VCU) School of Medicine commented, “It is
clear that compromised gut integrity is a contributing factor that
drives development of NASH and other inflammatory diseases. As
measured by our new method, larazotide was effective in maintaining
gut integrity in this pilot study. These results support the
rationale for advancement to clinical trials of drugs such as
larazotide that improve gut integrity. We look forward to
continuing to work with Innovate Biopharmaceuticals as they move
larazotide to the clinic and continue to develop their
pipeline.”
“The data not only underscore the use of dextran as a
plausible marker to detect gut epithelial integrity in a diet only
model of NASH, but further validate that the effects of larazotide,
our gut-specific lead clinical peptide, can affect the important
pathologic process of intestinal epithelial permeability. We
plan to further larazotide’s clinical development in 2019 for this
unmet need in gastroenterology and hepatology.” said Dr.
Christopher Prior, Chief Executive Officer of Innovate
Biopharmaceuticals, Inc.
In the study, researchers assessed the effect of larazotide on
gut integrity and intestinal permeability in vivo using a
proprietary model of NASH, which develops NASH solely due to a
high-fat, high-sugar “Western diet.” The development of NASH in
this model closely parallels human disease progression, including
the development of insulin resistance, obesity, dyslipidemia,
changes in the gut microbiome, and increased intestinal
permeability. Current methods for assessing gut integrity in
vivo require dosing with fluorescein isothiocyanate-dextran
(FITC-dextran) and then measuring the FITC fluorescence in animal
serum as a surrogate marker to gauge intestinal permeability or
“leaky-gut.” The new method developed by Sanyal Biotechnology can
be used in any mammal, has a broad dynamic range, and because it
does not harm the animal, allows for repeat measurements so that
response to drug therapies can be measured pair-wise in individual
animals rather than just groups. DIAMOND™ animals on a Western diet
have significantly higher levels of serum dextran than those on
normal diet beginning as early as eight weeks, when the first signs
of NASH develop in this strain, than those on a normal diet.
Researchers found that as NASH got progressively worse, the
animal’s guts became progressively leakier, suggesting that this
plays a role in driving the NASH pathology.
About NAFLD/NASH:Non-alcoholic
steatohepatitis (NASH) is a severe disease of the liver caused by
inflammation and a buildup of fat in the organ. In the United
States, NASH affects up to approximately 2-5% of the population. An
additional 10-30% of Americans have fat in their livers but no
inflammation or liver damage, a condition called non-alcoholic
fatty liver disease (NAFLD) or “fatty liver.” The underlying cause
of NASH is unclear, but it most often occurs in persons who are
middle-aged and overweight or obese. It has been shown that
chronic liver diseases, including NAFLD and NASH, may cause
perturbations in the epithelial lining of the gut, and disrupt
barrier integrity, causing a normal intestine to become more
permeable. This “leaky gut” could cause passage of unwanted toxins
and antigenic components to “cross-talk” to the liver via the blood
circulation causing inflammation and damage to hepatocytes. This
gut-liver axis is an emerging area of research in chronic liver
diseases, such as NAFLD and NASH.
About Sanyal Biotechnology, Inc.: Sanyal
Biotechnology, Inc. is a contract research organization built to
serve the needs of clients who seek a more physiologically relevant
small animal model for their preclinical research into liver
diseases and other comorbidities resulting from the metabolic
syndrome. The company develops customized studies to screen
compounds of interest based on customized end-points, while
providing expert interpretation of data. SBI offers a flexible
menu of core services beyond histopathology carried out in
an Association for Assessment and Accreditation of Laboratory
Animal Care (AAALAC) accredited and GLP
environment. Sanyal Biotechnology also offers PK and
toxicology work on the DIAMOND™ model and have successfully induced
autoimmune hepatitis (AIH). The company offers other models
including PK, toxicology and a variety of diets for NASH, fibrosis,
and hepatocellular carcinoma studies including ELISA, PCR, blot
work, and a propriety “leaky gut” assay.
About Innovate Biopharmaceuticals,
Inc. (Nasdaq: INNT): Innovate is a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases. Innovate’s lead drug
candidate, larazotide acetate, has a mechanism of action that
renormalizes the dysfunctional intestinal barrier by decreasing
intestinal permeability and reducing antigen trafficking, such as
gliadin fragments in celiac disease and bacterial toxins and
immunogenic antigens in NASH. In several diseases, including
celiac disease, NASH, Crohn’s disease, ulcerative colitis, and
irritable bowel syndrome (IBS), the intestinal barrier is
dysfunctional with increased permeability.
In celiac disease, larazotide is the only drug which has
successfully met its primary endpoint with statistical significance
in a Phase 2b efficacy clinical trial (342 patients). Innovate
completed the End of Phase 2 Meeting with the FDA in 2017
and is preparing to begin Phase 3 registration clinical trials for
celiac disease, targeted to commence in the first half of 2019.
Nearly 600 subjects have been exposed to larazotide in clinical
trials, and a safety profile comparable to placebo has been
demonstrated. Larazotide has received Fast Track designation from
the FDA for celiac disease.
Forward Looking Statements This press release
includes forward-looking statements including, but not limited to,
statements related to the development of drug candidates, our
operations and business strategy. The forward-looking statements
contained in this press release are based on management’s current
expectations and are subject to substantial risks, uncertainty and
changes in circumstances. Actual results may differ materially from
those expressed by these expectations due to risks and
uncertainties, including, among others, those related to our
ability to obtain additional capital on favorable terms to us, or
at all, including, without limitation, to fund our current and
future preclinical studies and clinical trials; the success, timing
and cost of our drug development program and our ongoing or future
preclinical studies and clinical trials, including, without
limitation, the possibility of unfavorable new clinical and
preclinical data and additional analyses of existing data, as well
as the risks that prior clinical and preclinical results may not be
replicated; the lengthy and unpredictable nature of the drug
approval process; and our ability to commercialize our product
candidates if approved. These risks and uncertainties include, but
may not be limited to, those described in our Quarterly Report on
Form 10-Q filed with the SEC on August 14, 2018, and
in any subsequent filings with the SEC. Forward-looking
statements speak only as of the date of this press release, and we
undertake no obligation to review or update any forward-looking
statement except as may be required by applicable law.
Sanyal Biotechnology, Inc.Rebecca Caffrey,
Ph.D., MBAChief Executive OfficerEmail:
rebecca@sanyalbio.com www.sanyalbio.com
Innovate Biopharmaceuticals, Inc.Jennifer K.
Zimmons, Ph.D.Investor RelationsTel:
+1-917-214-3514Email: jzimmons@innovatebiopharma.com www.innovatebiopharma.com
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