BEVERLY, Mass., Oct. 26, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the completion of the Phase 2 trial (see link NCT02324335) of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy (CRT). The final patient in the Phase 2 randomized, placebo-controlled clinical trial completed their post-therapy follow-up examination this week. The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter.
The primary objectives of the trial are the evaluation of the efficacy of Brilacidin-OM in reducing the incidence of severe OM (WHO Grade ≥3) compared to placebo during seven weeks of study treatment/CRT, and assessment of the safety and tolerability of this novel OM oral rinse therapy. A secondary objective includes evaluating the efficacy of Brilacidin in reducing the duration of severe OM.
The completion of the trial represents an important milestone, positioning the Company to address a significant unmet medical need. There are currently no FDA-approved drugs for preventing OM in patients with Head and Neck Cancer receiving chemoradiation. This painful condition affects upwards of 90 percent of patients in this population as well as a large number of patients receiving CRT for other cancers.
The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.
“By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It’s a horribly debilitating condition that causes tremendous suffering and leads to corresponding delays in clinical care, adding to costs and complications, for those who experience it. We look forward to compiling and releasing the topline Brilacidin-OM data, toward advancing it into a potential pivotal Phase 3 clinical trial—a final step toward Brilacidin-OM possibly emerging as the world’s first-ever approved preventative treatment for Oral Mucositis in this population.”
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
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About the Company
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI) is publicly-traded under the company symbol “IPIX”. The Company is clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and a Phase 2b study is ongoing. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo. The Company is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Topline results are now available for the Phase 2, open label Proof-of-Concept trial, treating patients with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. 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.
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