Innovate Biopharmaceuticals Submits Orphan Drug Application to FDA for Pediatric Ulcerative Colitis Indication

RALEIGH, N.C., July 12, 2017 -- 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 Colitis
Ulcerative 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-108
INN-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 Statements
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; 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
[email protected]
www.innovatebiopharma.com