Innovate Biopharmaceuticals Enters into a Collaboration on Larazotide’s Effect on Improving the Microbiome of Children with...
July 31 2018 - 7:00AM
Innovate Biopharmaceuticals Inc. (Nasdaq:INNT), a clinical stage
biotechnology company focused on developing novel medicines for
autoimmune and inflammatory diseases, announced today it has agreed
to collaborate with James P. Nataro, MD, PhD, MBA, the Benjamin
Armistead Shepherd Professor and Chair, Director of Children's
Services, UVA Children's Hospital of the University of Virginia
School of Medicine, whose research is focused on the study of
enteric bacteria and their roles in health and disease.
Dr. Nataro commented, “I am excited by this
collaboration. Abnormalities of intestinal permeability
underlie a host of human diseases such as environmental enteric
dysfunction, known as EED. EED is a disorder that afflicts
millions of children around the world, leading to growth faltering,
cognitive delay and impaired resistance to infection.”
Dr. Nataro has published extensively on intestinal
infection and gut health among children in the U.S. and around the
world. Dr. Nataro’s lab is funded by the National Institutes of
Health (NIH) and independent foundations. His current work on
larazotide is funded by the Bill and Melinda Gates Foundation.
Christopher Prior, Ph.D., CEO of Innovate, stated,
“Larazotide is the only known molecule in late stage clinical
trials that specifically restores intestinal barrier
function. We are pleased to be collaborating with Dr. Nataro,
and the University of Virginia School of Medicine to research the
effects of larazotide on EED. We believe that EED is an unmet
need with no current treatment and a serious health concern for
millions of children globally.”
About EED
Environmental enteric dysfunction is a common
malady afflicting millions of children who live in impoverished
circumstances around the world. EED is characterized by intestinal
inflammation and abnormal permeability, and results in growth
faltering and malnutrition. Although the precise cause of EED
remains elusive, gut bacteria are thought to play a role in its
pathogenesis.
About Innovate Biopharmaceuticals,
Inc. (Nasdaq:INNT)
Innovate is a clinical stage biotechnology company
focused on developing novel therapeutics for immuno-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 non-alcoholic
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.
In celiac disease, larazotide is the only drug
which has successfully met the primary endpoint with statistical
significance in a Phase 2b efficacy clinical trial (342 patients).
Innovate successfully 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 later in 2018. In clinical trials testing
of more than 800 patients, larazotide demonstrated a favorable
safety profile comparable to placebo for long-term chronic
administration. Larazotide has received Fast Track designation from
the FDA for celiac disease.
Forward Looking StatementsThis
press release includes forward-looking statements including, but
not limited to, statements related to our operations, the potential
of the products we are developing and our 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, the success, timing and cost
of our drug development program and our ongoing or future clinical
trials, 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 Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (the “SEC”) on
March 14, 2018, our Quarterly Report on Form 10-Q filed with the
SEC on May 15, 2018, and our 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:
Kendyle WoodardTel: +1 (919) 275 –
1933investor.relations@innovatebiopharma.comwww.innovatebiopharma.com
Innovate Biopharmaceutic... (NASDAQ:INNT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Innovate Biopharmaceutic... (NASDAQ:INNT)
Historical Stock Chart
From Apr 2023 to Apr 2024