BEVERLY, Mass., Oct. 12, 2018 — Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide this update on Brilacidin as a novel inhibitor of Phosphodiesterase 4 (PDE4), an important aspect of its mechanism of action. PDE4 inhibitors, such as apremilast and crisaborole—the latter having been acquired by Pfizer in 2016 from Anacor—for dermatological conditions, are a well-established and actively marketed class of drugs used to treat a variety of autoimmune and inflammatory diseases. PDE4 inhibition is being studied as a novel therapeutic avenue in treating Inflammatory Bowel Disease (IBD).
Brilacidin’s Inhibition of PDE4
Due to multiple immunoregulatory functions, defensins—small antimicrobial peptides widely expressed and produced in skin and mucosal surfaces, as well as in neutrophils—play a critical role in mediating human health and disease. Brilacidin, the design of which was modeled on defensins, has been shown to be a potent regulator of immune response (data on file). It suppresses various pro-inflammatory mediators (e.g., TNF-α, IL-1β, IL-8, IL-6, MMP-9, MCP-1). One potentially central aspect of Brilacidin’s mechanism of action concerns its modulation of the cyclic adenosine monophosphate (cAMP) pathway, an established therapeutic target, through its ability to inhibit Phosphodiesterase 4 (PDE4) as well as Phosphodiesterase 3 (PDE3).
In more detail, pre-clinical studies have demonstrated that Brilacidin inhibits PDE4B2 and PDE3A in vitro, in a dose dependent manner. Brilacidin demonstrated similar IC50 values against both PDE4 (biochemical) and cytokine release in cell-based assays, suggesting Brilacidin has good cell membrane permeability. Localized clinical administration enables Brilacidin concentrations that markedly exceed in vitro IC50 values, and, consequently, provides for increased concentrations of cAMP.
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The overall effect of Brilacidin’s ability to modulate cAMP levels—complementing other aspects of its broad immunomodulatory profile—supports its potential to treat a number of chronic, autoimmune and inflammatory diseases related to issues of innate immunity, such as: IBD, atopic dermatitis, and others.
While Brilacidin inhibition of PDE4, similar to multiple established FDA-approved drugs, contributes to its therapeutic potential, its pleiotropic actions likely offer additional unique advantages beneficial to multiple clinical applications.
Brilacidin for Inflammatory Bowel Disease
Reflective of Brilacidin’s treatment potential in IBD, the drug candidate has successfully been tested in a proof-of-concept study in distal colitis. Trial results showed that a majority of patients treated with Brilacidin achieved clinical remission, including mucosal healing as evidenced by endoscopic review. Plans include developing Brilacidin in an oral dosage form to treat more complex cases of IBD, such as Ulcerative Colitis and Crohn’s Disease.
As released previously, the Company has been asked, by invitation-only, to present at an upcoming IBD conference—“IBD Innovate 2018”—hosted by the Crohn’s & Colitis Foundation and scheduled for November 13, 2018. The scientific poster—titled “Brilacidin for Inflammatory Bowel Disease: A Novel, Non-Corticosteroid, Non-Biologic Drug Candidate in Clinical Development”—to be presented at the conference will be available in the Events and Presentations section of the Company website on November 13, 2018.
Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals, commented, “The results from our completed distal colitis study suggest Brilacidin could emerge as a novel, non-corticosteroid, and non-biologic, treatment for more extensive forms of bowel disease. We look forward to highlighting our data and sharing program insights at the IBD Innovate 2018 conference, attended by GI experts and pharmaceutical industry representatives.”
Linked below is additional information, published in a blog on the Company’s website, elaborating on how Brilacidin—given its unique and broad mechanism of action—is a promising candidate for continuing IBD drug development.
“Deficient Defensins and Missing Mucins in the Pathogenesis of Inflammatory Bowel Disease” http://www.ipharminc.com/new-blog/2017/10/24/deficient-defensins-and-missing-mucins-in-the-pathogenesis-of-inflammatory-bowel-disease
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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. 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. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis. 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, our future drug development plans, other statements regarding future product developments, 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 to Aspire Capital; 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.
INVESTOR AND MEDIA CONTACT Innovation Pharmaceuticals Inc. Leo Ehrlich [email protected]