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Innovation Pharmaceuticals Completes Gastric Fluid Testing of Brilacidin Supporting Development of an Oral Dosage Form to Treat Inflammatory Bowel Disease
BEVERLY, Mass., Jan. 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.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, including planned Phase 3 trials of Brilacidin, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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Innovation Pharmaceuticals Inc.