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Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis
Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., March 15, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide shareholders with a status report on the development of Brilacidin-OM, Innovation Pharma’s novel defensin mimetic drug candidate for the prevention and treatment of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Over the last weeks, there has been significant attention directed to this disease. Additional perspectives on the SOM market—an area of great unmet medical need, attracting investment and industry attention – and the Company’s prospects in this emerging market are discussed.\n Summary Points Brilacidin-OM viewed by Company to have significant competitive advantages and less challenges than other OM drug candidates:  Prevention: Effective reduction of SOM incidence, beyond providing symptom relief, would be a critical factor toward successful commercialization Delivery: Brilacidin-OM developed in sachet packets offers a portable, quick-mixing, “instant” oral rinse therapy—patients and providers likely would more readily adopt  Cost: Brilacidin-OM avoids costly manufacturing and logistics of sterile IV therapy competitors amid a regulatory environment demanding lower drug prices   Company preparing for U.S. Food and Drug Administration (FDA) meeting to discuss Brilacidin-OM development plan The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA. The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of SOM (WHO Grade ≥ 3) compared to placebo. A key secondary endpoint in the trial, delaying the onset of SOM, also was also met. Brilacidin is being developed under FDA Fast Track Designation. SOM Landscape In cases of SOM, patients cannot eat solid food (Grade 3) and cannot consume either solids or liquids (Grade 4)—a situation that can result in weight loss and, most critically, suspension of cancer ther...