Continued execution toward start of the first
phase 3 celiac disease clinical trial in the current quarter with
key sites for trial launch selected and active recruitment efforts
underway
Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases, announced today that
larazotide acetate, a new class of medicine based on gut-restricted
peptides which re-normalize the intestinal epithelial barrier and
gut-liver axis, is the first drug with this novel mechanism to
shown improvements in validated NASH biomarkers and endpoints. Key
topline findings from a biopsy-proven translational mouse model of
NASH (the AMLN-diet Gubra NASH mouse model) will be presented at an
Analyst Meeting at the Digestive Disease Week (DDW) conference on
May 20, 2019 in San Diego as well submitted to The Liver Meeting of
the American Association for the Study of Liver Diseases (AASLD) in
fall, 2019.
Recent AchievementsClinical
- Active patient recruitment efforts underway
- Selected more than 100 clinical research sites to participate
in our registration trial: CeD-LA-3001 Study: A Phase 3,
Randomized, Double-Blind, Placebo Controlled Study to Evaluate the
Efficacy and Safety of Larazotide for Relief of Persistent Symptoms
in Patients with Celiac Disease on a Gluten Free Diet.
R&D
- Immuno-oncology: started academic collaboration with Institut
Gustave Roussy to study regulation of intestinal permeability and
the gut microbiota using larazotide in immuno-oncology checkpoint
inhibitor failure preclinical models
Upcoming Milestones
- Start of patient screening and randomization for the first
phase 3 celiac disease trial
- NASH data presentation at Analyst Meeting at Digestive Disease
Week (DDW) conference on May 20, 2019 in San Diego
- Further updates on NASH pathway for clinical development
- Continuation of pre-clinical studies for alcoholic
steatohepatitis (ASH)
- Initiation of additional scientific and clinical
collaborations
NASH Pre-clinical Data HighlightsIn a 12 week
preclinical study of larazotide acetate combined with obeticholic
acid (OCA), data demonstrated statistically significant reductions
in plasma total cholesterol (p<0.001), absolute (p<0.05) and
relative liver weights (p<0.01), relative (p<0.001) and total
liver cholesterol (p<0.001), and relative (p<0.01) and
absolute liver triglycerides (p<0.001), when compared to vehicle
control animals that did not receive any larazotide or OCA. The
non-alcoholic fatty liver disease activity score (NAS score), the
clinical measure of NASH activity, improved in the majority of
animals treated with the combination of larazotide/OCA when
compared to vehicle (p<0.001). Histological steatosis scores
trended positively, and lobular inflammation was statistically
significantly improved (p<0.01) in the larazotide/OCA group when
compared to vehicle control animals.
Dr. Stephen Harrison, Medical Director of Pinnacle Clinical
Research in San Antonio, Texas, an expert in clinical trials for
NASH said, “These preclinical data, demonstrating a synergistic
effect of larazotide, which targets intestinal permeability, when
combined with obeticholic acid, a well characterized farnesoid X
receptor (FXR) agonist’. Dr Harrison added, “the data
mandates a clinical study to understand this novel mechanism’s
effect in patients. There is a high unmet need for NASH and agents
which may improve existing modalities via novel mechanisms would
greatly benefit patients.”
Sandeep Laumas, M.D., CEO of Innovate, said, “The first quarter
of 2019 was focused on continued preparation for the first celiac
disease phase 3 clinical trial. Larazotide’s positive effect in a
pre-clinical model has, for the first time shown, a novel mechanism
for treatment of NASH in combination with other drugs. We are very
excited with this data along with previous preclinical studies
(AASLD 2018 abstracts) could seek to move to a proof-of concept
clinical trial after receipt of additional financing. The unique
mechanism of larazotide has consistently proven itself in a series
of models for multiple diseases. We are also awaiting data from the
immuno-oncology microbiome study which is studying larazotide’s
effect on converting checkpoint inhibitor / PD-1 non-responders to
responders via modulation of gut permeability and the
microbiome.”
2019 First Quarter Financial ResultsAs
previously disclosed, as of March 31, 2019, Innovate had estimated
unaudited cash and cash equivalents of $11.5 million, compared to
$5.7 million at December 31, 2018. This is a preliminary unaudited
estimate of the cash and cash equivalents of the Company as of
March 31, 2019.
Webcast As previously announced, Innovate plans
to host a conference call at 8:00 am ET today, April 29, 2019, to
discuss certain of its financial results for the first quarter
ended March 31, 2019, and to provide operational updates. Please
visit the Investor section of Innovate’s website for further
details on accessing the webcast.
A live and archived audio webcast of the conference call will be
available on the Events and Presentations page of Innovate’s
corporate website at www.innovatebiopharma.com.
About NAFLD/NASH: Nonalcoholic 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 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/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/NASH.
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 nonalcoholic steatohepatitis (NASH). In several
diseases, including celiac disease, NASH, Crohn’s disease,
ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes
mellitus (T1DM), chronic kidney disease (CKD), the intestinal
barrier is dysfunctional with increased permeability.
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, capital raising, our expected
financial results, and corporate updates. 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, including, without
limitation, raising additional funds for our Phase 3 registration
trial for INN-202, and 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. These risks and
uncertainties include, but may not be limited to, those described
in our Annual Report on Form 10-K filed with
the SEC on March 18, 2019, 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.
SOURCE: Innovate Biopharmaceuticals, Inc.
Contact:Jennifer K. Zimmons, Ph.D.Investor
RelationsTel: +1-917-214-3514Email:
jzimmons@innovatebiopharma.comwww.innovatebiopharma.com
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