Guidance to Inform Brilacidin Oral Rinse Phase 3 Program for Prevention of Severe Oral Mucositis
BEVERLY, Mass., May 01, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today it has received Food and Drug Administration (FDA) End-of-Phase 2 (EoP2) meeting minutes, helping to guide the Company’s planned Phase 3 program for Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).
During the EoP2 meeting convened in December 2018, the Company and FDA agreed to an acceptable Brilacidin Phase 3 development pathway. The guidance from the FDA now also helps to frame ongoing discussions with the European Medicines Agency (EMA) as part of the Scientific Advice process. The purpose of both of these interactions is to ensure that proposed plans meet regulatory requirements for New Drug Application (NDA)/Marketing Authorization Application (MAA) filings and, ultimately, to obtain approval of Brilacidin for SOM in HNC in both the United States and Europe.
“Productive regulatory meetings for our Brilacidin SOM program with U.S. and European agencies are significant Company milestones,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Brilacidin oral rinse, to decrease the incidence of SOM, represents a potential future regimen for millions of head and neck cancer patients where no approved drug is available today. Furthermore, our hope is that Brilacidin will eventually emerge as a treatment for other indications where SOM also is a frequent side-effect of cancer therapies.”
“It is time that the current standard of care for SOM takes a leap forward and a new market emerges,” added Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “I am reminded of drugs for not only rare diseases that were overlooked by the market during development and then went on to become ‘company makers,’ but also a drug such as Tagamet. Eventually, it became the first blockbuster drug ever by treating the common problem of acid reflux, a disease that was casually written off for decades as not having an effective treatment beyond antacids. Treatment-related SOM in cancer patients is a real problem worldwide, affecting millions of patients, with physical and financial ramifications that genuinely must be addressed beyond today’s magic mouthwashes. And, we are currently the only company with an oral drug candidate being advanced into late-stage trials, positioned to fill this unmet need. I greatly look forward to initiating our planned Phase 3 program, adding further credibility and value to our Brilacidin Franchise.”
About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and was well-tolerated.
Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs in clinical development.
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.
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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 to decrease the incidence of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints. 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, receipt of the official meeting minutes from the FDA and the contents 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 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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