BEVERLY, Mass., Sept. 24, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a comparative perspective on the development of Brilacidin for the prevention of severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC). The late-stage drug candidate, one of the few drugs currently in clinical development shown to reduce the incidence of SOM, further advantaged by its convenient mode of administration as an oral rinse, is emerging as clearly differentiated and highly promising.
Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is favorably positioned compared to other investigational Oral Mucositis (OM) drugs currently in clinical development.
“Brilacidin for Oral Mucositis: At-a-Glance Comparative Data Presentation with Other Investigational OM Drugs” http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
The Market Opportunity and Unmet Need in Oral Mucositis
Various drug companies in the OM space are conducting mid-and-late-stage clinical trials, with one private company recently raising $150 million to fund further development of its OM drug candidate. We believe the magnitude of such a sizable investment commitment confirms our own assessment that an effective drug to prevent—or even reduce the duration of SOM—has the potential to capture a substantial new market.
OM represents a large unmet medical need and is estimated to be a $1 billion market opportunity, increasingly garnering substantial pharmaceutical industry interest. Patients desperately await effective OM treatments, as relayed in a video on the painful and debilitating side-effects of the condition published on the “Healthy Body, Healthy Mind” website.
“The results of the Brilacidin OM Phase 2 are compelling,” said Company Scientific Advisor and OM expert, Stephen T. Sonis, DMD, DMSc, of Brigham and Women's Hospital. “The lack of preventive or definitive treatment options for patients at risk of, or suffering from, OM is a consistent source of patient misery and leads to costly and clinically significant downstream consequences. I enthusiastically anticipate the next phase in Brilacidin’s clinical development.”
Brilacidin Oral Rinse Development Focus and Competitive Advantages
Innovation Pharmaceuticals has successfully completed a randomized, placebo-controlled Phase 2 clinical trial (see NCT02324335). Data analysis showed that Brilacidin delivered a statistically significant therapeutic benefit by decreasing the incidence of SOM (WHO Grade ≥3) in HNC patients receiving the more aggressive chemotherapy regimen—cisplatin administered in high concentration (80-100 mg/m2), approximately every 21 days (q3wk)—as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly. The q3wk dosing regimen aligns with the current standard-of-care for cisplatin chemotherapy. Other previously released results indicate that Brilacidin also delayed the onset and reduced the duration of SOM.
Based on these consistent and compelling trial results across multiple endpoints, the Company believes Brilacidin occupies a lead position among OM drug candidates being evaluated in clinical pipelines. Most potential competitor drugs target mainly symptom relief and not the prevention of SOM, and/or are disadvantaged by not having as patient-friendly modes of delivery (e.g., IV). 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 to both doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse one day gain regulatory approval.
“We have analyzed the full dataset from our Phase 2 study, versus other publicly available datasets from comparable studies, and believe Brilacidin stands apart from the competition in reducing the incidence of SOM in this patient population,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer of Innovation Pharmaceuticals. “We, along with potential pharmaceutical industry partners, are excited that SOM incidence reduction is an achievable outcome. Significantly reducing incidence of SOM obviously provides the greatest therapeutic benefit to patients, rather than merely decreasing symptoms, as is the case with today’s limited palliative-only OM therapies.”
“In aggregate, the data from the Brilacidin Phase 2 study was impressive and we will consider expanding the drug to other cancer indications in the future,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “For now, we want to maintain our focus on the shortest path to commercialization, which we believe is best achieved by targeting treatment in the more aggressive chemotherapy regimens, in which cases of severe oral mucositis abound.”
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of 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 SOM, 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 and patient-friendly oral rinse, the Company believes that it would be attractive to both doctors and patients, which would translate to substantial market penetration should it one day gain regulatory approval. Innovation Pharmaceuticals also believes that it would be a preferred treatment for payers due to being inherently less costly than potential IV infusion therapies.
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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.