Innovate Biopharmaceuticals’ Dose Response Data for Larazotide Acetate Demonstrating Its Unique Mechanism of Action and App...
December 28 2017 - 9:00AM
Innovate Biopharmaceuticals, Inc. (“Innovate”), a clinical stage
biotechnology company focused on developing novel medicines for
autoimmune and inflammatory disorders, announced today it has
submitted an abstract for presentation at the Digestive Disease
Week (DDW) conference in Washington D.C., June 2-5, 2018, entitled
“Larazotide stimulates recovery of ischemic-injured intestine in a
dose-dependent manner associated with restoration of tight
junctions.”
Dr. Anthony Blikslager, professor of gastroenterology at North
Carolina State University, who conducted the experiments, said,
“Our recent work has revealed the likely mechanisms for an optimal
dose for larazotide, which has also been noted in recent clinical
trials. These mechanisms include the production of inhibitory
peptides cleaved from the parent compound at high larazotide doses.
Nonetheless, larazotide induces a remarkably robust recovery
response in severely injured tissues at its optimal dose.”
The data reveal a narrow dose response for larazotide with the
higher doses showing inhibition. Further studies have identified
specific breakdown fragments of larazotide that can act as
antagonists causing inhibition as the larazotide dose increases and
the fragments accumulate. Innovate believes these data explain the
clinical findings that significant efficacy is achieved in a narrow
low dose range while inhibition occurs above a higher dose
threshold.
Dr. Blikslager is widely published on studying mechanisms
responsible for maintenance and restoration of the intestinal
barrier, with the ultimate objective of pharmacologically restoring
the mucosal barrier in patients suffering from diseases associated
with increased intestinal permeability. Restoring the intestinal
barrier would be significant for patients suffering from diseases
such as intestinal ischemia/reperfusion injury, inflammatory bowel
diseases, and gastric ulcer disease due to the potential medical
complications associated with these diseases.
About Innovate Biopharmaceuticals,
Inc.:
Innovate is a clinical stage biotechnology company focused on
developing novel medicines for autoimmune and inflammatory
disorders.
On July 3, 2017, Innovate announced that it had signed a
definitive Merger Agreement with Monster Digital, Inc.
(Nasdaq:MSDI), under which the shareholders of privately-held
Innovate Biopharmaceuticals, Inc. will become the majority owners
of Monster Digital.
Innovate’s lead drug candidate, larazotide acetate
(INN-202), has successfully met its primary endpoint in an efficacy
clinical trial for celiac disease. Larazotide successfully
completed the End of Phase 2 Meeting with the FDA to prepare for
expected Phase 3 clinical trials for larazotide in celiac disease
in 2018. In clinical studies in more than 800 patients, larazotide
demonstrated a favorable safety profile comparable to placebo, due
to what Innovate believes is its lack of systemic absorption from
the small bowel. Larazotide has received Fast Track designation
from the FDA.
Larazotide, an oral peptide formulated into a capsule, has a
mechanism of action which decreases intestinal permeability and
regulates tight junctions by reducing antigen trafficking across
epithelial cells in the intestines. Innovate believes that
larazotide is the only drug in the clinic with this mechanism of
action of reducing intestinal permeability. Increased intestinal
permeability, sometimes referred to as “leaky gut,” has been widely
recognized in the literature as a gateway to multiple autoimmune
diseases, including celiac disease, irritable bowel syndrome (IBS),
inflammatory bowel diseases (IBD, Crohn’s and ulcerative colitis),
type 1 diabetes mellitus (T1DM), nonalcoholic steatohepatitis
(NASH), chronic kidney disease (CKD) and several others.
This press release contains forward-looking statements,
including statements regarding the clinical development of our
product candidates, which are subject to risks and uncertainties
that could cause actual results to differ materially. Reported
results should not be considered as an indication of future
performance. These risks and uncertainties include, but are not
limited to: risks associated with the success, cost and timing of
our product development activities and clinical trials; the
approval and commercialization of our product candidates; the
timing of data submission, and risks of increased regulatory
requirements, amongst others. These forward-looking statements
speak only as of the date hereof. Innovate Biopharmaceuticals
disclaims any obligation to update these forward-looking
statements.
Contact:
Kendyle Woodard Tel: +1 (919) 275–1933 Ext. 1
investor.relations@innovatebiopharma.com
www.innovatebiopharma.com
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