Innovation Pharmaceuticals has signed an agreement to use OralogiK — an advanced tablet-coating technology patented by BDD Pharma — to develop tablets for targeted oral delivery of Brilacidin for treating people with inflammatory bowel disease (IBD). The technology transports the medicine from the mouth, through the digestive system, to the colon, where it is needed.
Brilacidin is a synthetic small molecule that structurally resembles some of the proteins the body makes to fight off bacteria and other microbial invaders. Because of this, it’s being tested as an antibiotic. However, Brilacidin also has immunomodulatory properties — meaning it can decrease inflammation and even promote wound healing — that make it a potential treatment for IBD.
Data from a proof-of-concept clinical trial in people with ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS) — a type of ulcerative colitis that itself is a form of IBD — demonstrated the safety and efficacy of this treatment. In that trial, Brilacidin was administered via enema. Most patients treated with Brilacidin went into clinical remission.
Enemas are not generally considered the most desirable way for patients to take their medicine. However, getting a therapeutic molecule from the mouth, all the way through the digestive track, to the intestines — where it is actually needed — can be a challenge. That’s where OralogiK comes in.
The tablet technology uses a layer over the actual drug that is removed as the tablet passes through the digestive system. Once the tablet reaches the intestine and colon, this layer is completely gone. Then, and only then, the payload — in this case, brilacidin — is released, allowing specific, targeted delivery to the site of disease activity.
The hope is that delivering Brilacidin via OralogiK will allow the drug to be taken more easily — orally, as a pill — while still retaining its efficacy. Of course, clinical trials will be needed to see whether this is actually the case.
“We’re confident in the activity of Brilacidin in treating IBD and believe that OralogiK will be integral to success in efficiently delivering the drug to the colon,” Arthur P. Bertolino, MD, PhD, president and chief medical officer at Innovation Pharmaceuticals, said in a press release.
“BDD Pharma is delighted to sign this agreement with Innovation Pharmaceuticals for a colon-targeted formulation of Brilacidin for treatment of Ulcerative Colitis and other gastrointestinal disease conditions,” added Howard Stevens, the chairman of BDD Pharma.
The companies will collaborate to start clinical trials testing this combination. Such trials are planned to begin near the end of 2019, or soon thereafter.
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