Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, has signed an agreement with BDD Pharma, an award-winning drug delivery company specializing in modified and controlled release oral formulations, to immediately begin the development of tablets for targeted oral delivery of Brilacidin to the colon.
To develop the oral formulation, BDD Pharma will utilize its patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting.
BDD’s OralogiK™ technology has been specifically designed to work independently of variations in the GI tract and has shown accurate and consistent performance in clinical studies in several hundred subjects. The unique erosion properties of the technology ensure that when the tablet reaches the colon, the targeted layer has been removed and the drug is rapidly released, maximizing opportunities for therapeutic benefits in the colonic lumen.
The delivery system utilizes well-established manufacturing techniques and excipients which will help to expedite the development of the Brilacidin oral tablet and subsequently maximize return on investment as Brilacidin advances along the regulatory path to market.
Data from the successfully completed clinical trial of Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) provided evidence of the drug’s effectiveness in safely treating the disease. The Company believes that that the combination of Brilacidin and OralogiK™ will overcome the challenge faced by existing Inflammatory Bowel Disease (IBD) drugs to efficiently and specifically reach the target to deliver the payload. The end goal is to disrupt the market by creating a world-class, affordable small molecule in tablet form as a new treatment option with clear advantages over today’s commonly used biologics for patients with extensive IBD, such as Ulcerative Colitis (UC).
BDD will provide further expertise and resources by collaborating with the Company to accelerate initiation of clinical trials. The trials, evaluating Brilacidin for IBD in tablet form, are targeted to commence later this year or early thereafter.
“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. We are also delighted to be able to engage BDD’s expertise in gamma scintigraphy and early clinical testing to take the Brilacidin program forward expediently into clinical investigation of the new dosage form,” commented Professor Howard Stevens, Chairman of BDD Pharma.
“BDD’s OralogiK™ technology is transformational, with its unrivaled control of targeted drug delivery attracting significant interest from pharmas, big and small,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “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. Global pharmaceutical companies have demonstrated a high demand, in deal size and volume, for novel oral IBD drugs—and our goal is to further validate Brilacidin in this space. First-in-human testing using the tablet form should help unlock the tremendous potential in Brilacidin for IBD.”