Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
BEVERLY, MA – December 12, 2017 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today that the European Patent Office has granted a European patent for Brilacidin, the Company’s first-in-class defensin-mimetic, in the prevention and control of Oral Mucositis (OM). Brilacidin-OM is being developed under an FDA Fast Track designation for this indication.
The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea.
The European patent is part and parcel to the Company’s strategy to develop and commercialize Brilacidin-OM internationally through licensing agreements. An estimated 700,000 (source: GLOBOCAN) Head and Neck Cancer (HNC) patients worldwide will develop OM this year, with the figures expected to climb to over one million annually by 2023. In spite of OM incidence rates ranging as high as 100 percent in HNC, there currently are no FDA-approved drugs for the prevention and treatment of OM in these types of cancer patients receiving chemoradiation.
“We are looking at a global product opportunity with OM that is extremely attractive and intellectual property protection is critical. With no approved drugs for our initial target indication in preventing OM in HNC, the first company to commercialize a safe and effective drug would undoubtedly command a significant portion of the market, which is estimated to be at least $1 billion worldwide,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
“The topline data released yesterday from our Phase 2 trial showed a meaningful reduction in the incidence of severe OM even compared to a rate somewhat lower than historic norms in the placebo arm, demonstrating Brilacidin-OM’s clear effect in preventing this extremely painful, and at times even deadly, consequence of chemoradiation in a majority of HNC patients treated with the drug. I can’t imagine a physician not wanting to prescribe, and a patient not wanting to use, a simple oral rinse like Brilacidin-OM if it would mean cutting the chance of developing severe OM by as much as 38.7 percent, as observed in patients who adhered to the requirements of the trial protocol,” Mr. Ehrlich continued.
“Given the positive topline data, the Company is compelled to aggressively seek a development path that will most efficiently bring Brilacidin-OM to patients in need,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We intend to work diligently with the FDA and other health authorities, on a worldwide basis, and ideally in collaboration with interested potential partners, to achieve this goal. We have a potential “game changer” asset with Brilacidin-OM, able to make a big impact on a cancer patient’s well-being, and we are in the privileged position of planning wholeheartedly for the next stage of development as we strive to be the first to fill a wide void in oncology as quickly as possible.”
About Brilacidin
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.
Learn more here:
http://www.ipharminc.com/brilacidin-1/
About Brilacidin-OM
Innovation Pharmaceutical’s first-in-class immunomodulatory drug candidate, Brilacidin, targets the prevention of severe Oral Mucositis (OM)—a common and debilitating side-effect of receiving chemoradiation therapy—in Head and Neck Cancer. Each year, OM affects hundreds of thousands of patients worldwide. Only a limited number of OM treatments are available, most of which are palliative in nature. A Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335) has been recently completed in which topline results demonstrate a reduced rate of severe OM (WHO Grade >3) in patients treated with Brilacidin-OM compared to those on placebo.
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About the Company
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI), formerly Cellceutix Corporation, 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 the Company more recently launched a Phase 2b study. 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 has recently completed a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer; topline results demonstrate a 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. The Phase 2b data showed 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”). Results are now available for the completed 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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