BEVERLY, MA – January 14, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders the Company has completed early testing evaluating the stability of Brilacidin, its novel defensin-mimetic drug candidate, in simulated gastric fluid—a synthetic form of the fluid found in the stomach.
Results showed very minimal degradation of Brilacidin across 4 hours, suggesting that a simple formulation of Brilacidin likely would not be subject to rapid breakdown once in the stomach. This finding should enable initial clinical testing with a simple formulation of the drug candidate delivered to the gut while a more elegant, tailored oral dosage form of Brilacidin is developed and refined, in parallel. The end goal would be to release Brilacidin selectively in the GI tract via targeted delivery technology.
“These gastric testing results are an important initial step in determining Brilacidin’s likely stability profile with simple oral delivery to the gut,” commented Francis A. Farraye, MD, MSc, Clinical Director, Section of Gastroenterology at Boston Medical Center, Professor of Medicine at Boston University School of Medicine and Scientific Advisor to Innovation Pharmaceuticals. “We were pleased to see that Brilacidin maintains ample integrity in simulated gastric fluid long enough to suggest it would allow for intact passage from the stomach into the gut where clinical disease manifests with Inflammatory Bowel Disease (IBD). One of the key advantages of Brilacidin, as a synthetic defensin mimetic, is the robustness of its design, which should help it to withstand potential degradation in the stomach. I very much look forward to working with Innovation as we aim to advance oral Brilacidin further into clinical development for the treatment of IBD.”
Planned next steps in the development of Brilacidin for oral delivery include clinical testing of Brilacidin in healthy volunteers to assess safety and toleration, the pharmacokinetic profile and effects on the gut’s microbiome. Clinical trials in IBD including Ulcerative Colitis and Crohn’s Disease, would then follow.
“This is a significant development for shareholders,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “A safe and effective oral formulation of Brilacidin would represent a substantial market opportunity given the high prevalence of the disease and need for novel IBD treatments. As the Company works on Phase 3 development of Brilacidin for Oral Mucositis, it is concurrently a high priority to keep making progress on the oral version of Brilacidin for IBD.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 5 million people worldwide, including 1 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 in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. Trial results showed that a majority of patients treated with Brilacidin achieved clinical remission (Modified Mayo scoring), including mucosal healing as 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.