Innovation Pharmaceuticals Announces Successful Formulation of Oral Brilacidin Tablets; Upcoming Clinical Trial to Target Delivery to the Colon

BEVERLY, Mass., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that BDD Pharma, the Company’s formulation partner in the area of Inflammatory Bowel Disease (IBD), has performed appropriate non-clinical studies that show the oral dosage form meets in vitro specifications for selective delivery of oral Brilacidin to the colon.

Brilacidin tablet design employs BDD Pharma’s patented technology to provide controlled erosion of a time-dependent barrier layer during small intestine transit. The first clinical trial of oral Brilacidin in the Company’s Ulcerative Colitis program is planned to commence in December 2019 in healthy volunteers in the United Kingdom. It will assess the safety, toleration, pharmacokinetics of Brilacidin, and whether it is being dispersed directly in the colon. Trial data will provide the basis to move forward in clinical development and further build upon the compelling efficacy and good safety results already observed in a completed using Brilacidin in a retention enema.

“We are delighted to have met the in vitro specifications for development of an oral Brilacidin product for targeted delivery to the colon and look forward to the upcoming clinical studies to confirm in vivo behaviour,” commented Professor Howard Stevens, Chairman of BDD Pharma.

“We are pleased to be working with BDD Pharma, with their sophisticated and proprietary approach to selectively delivering drugs to the gut - a complex reality,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Promising oral medications in development for IBD are scant given inherent delivery challenges. BDD’s OralogiK™ technology should enable us to quickly and accurately evaluate oral Brilacidin’s ability to be delivered in a targeted manner to the colon. If successful, Brilacidin’s treatment potential in IBD would be greatly enhanced, paving the way towards advanced clinical trials of Brilacidin in Ulcerative Colitis in 2020 using this technology.”

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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 (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. 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 Infection. 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 .

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 the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, 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 licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or 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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