BEVERLY, MA – June 6, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), 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.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
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BDD Pharma Ltd is a privately-owned drug delivery company specializing in the development of modified and controlled release oral formulations. BDD’s OralogiK™ technology is a tablet-in-tablet drug delivery system providing timed release, targeted release and the opportunity for complex bi- and tri-phasic release of one or multiple drugs. The OralogiK™ technology is protected with granted patents in the US, EU and Japan. Supported by investment from Archangels and the Scottish Investment Bank, BDD has in-house clinical trial capabilities for the conduct of gamma scintigraphic/ pharmacokinetic studies in humans. BDD Pharma signed two license agreements in 2018 for development of products based on its OralogiKTM technology.
For more information visit http://www.bddpharma.com.