Innovate Biopharmaceuticals Submits Orphan Drug Application to FDA for Pediatric Ulcerative Colitis Indication
July 12 2017 - 7:07AM
Innovate Biopharmaceuticals, Inc., a clinical stage biotechnology
company focused on developing novel medicines for autoimmune and
inflammatory disorders, announced today it has submitted an
application to the U.S. Food and Drug Administration seeking orphan
drug designation for INN-108 as an oral therapy proposed for the
treatment of pediatric ulcerative colitis.
“Orphan drug designation would expedite our
development of a therapy that we believe could bring relief to
children and teenagers suffering from active ulcerative colitis,”
said Innovate’s CEO Chris Prior, Ph.D. “There is an unmet need for
an effective treatment for this disease, and INN-108 is a promising
potential therapy. Our FDA submission is a major milestone toward
making this therapy available.”
Under the Orphan Drug Act of 1983, the FDA provides
incentives for companies developing treatments that are expected to
provide significant therapeutic advantage over existing treatments
and that target rare medical conditions affecting fewer than
200,000 U.S. patients per year. Incentives include seven-year
market exclusivity, tax credits on U.S. clinical trials,
fast-tracking of regulatory proceedings, and exemption from certain
fees.
On July 3, 2017, Innovate announced that it has
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, Inc. Subject to shareholder approval, the
combined company will advance its late-stage drug for celiac
disease, which Innovate believes is a significant unmet medical
need, into expected Phase 3 clinical trials.
About Ulcerative ColitisUlcerative
colitis is a chronic inflammatory bowel disease that mainly affects
the large intestine, or colon. Symptoms typically include constant
diarrhea mixed with blood, abdominal pain, increased bowel
movements, and in severe cases, weight loss and fatigue. Children
can also develop unique complications related to growth,
development, nutrition, pubertal maturation, bone mineral density
accretion and psychological impacts.
Though the disease can present at any age, it often
begins in teenagers and young adults. Various studies estimate that
there are between 13,700 and 87,600 cases of pediatric ulcerative
colitis in the United States, with most of those occurring in
children and teenagers aged 10 to 17.
More than 80 percent of patients have the mild to
moderate form of ulcerative colitis that is currently treated with
various formulations of 5-ASA, or mesalamine, a $2 billion market
in the United States. Due to the high failure rates (40 to 50
percent) of 5-ASA treatments, new treatments for ulcerative colitis
are needed.
About INN-108INN-108 is a novel
oral small molecule comprised of two moieties, mesalamine/5-ASA, a
currently approved agent for ulcerative colitis, and
4-aminophenylacetic acid (4-APAA), an immunomodulatory agent
approved in Japan for rheumatoid arthritis. The two agents are
covalently azo-bonded, thus only allowing their enzymatic
separation in the colon. Innovate’s preliminary data shows the
combination could be a more efficacious drug than mesalamine/5-ASA
approved treatments alone.
INN-108, which has successfully completed two Phase
1 clinical trials in the U.S. for mild to moderate ulcerative
colitis in both healthy adult subjects and adults with ulcerative
colitis, will initiate its Phase 2 trial in 2018. A liquid oral
formulation of INN-108 for ulcerative colitis is in development for
greater convenience for pediatric use.
About Innovate Biopharmaceuticals,
Inc.
Innovate is a clinical stage biotechnology company
focused on developing novel autoimmune/inflammation therapeutic
drugs.
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 late 2017. 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 also 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.
Forward-Looking StatementsThis
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; 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
investor.relations@innovatebiopharma.com
www.innovatebiopharma.com
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