The patent (U.S. Patent Number 10206894) covers methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically acceptable salts.
The new patent broadens the Company’s Intellectual Property footprint in the oral mucositis therapeutic area, and further builds on other recently assigned patent protections for Brilacidin, the Company’s defensin-mimetic drug candidate.
Brilacidin has been successfully evaluated in clinical trials in oral mucositis, inflammatory bowel disease and serious skin infections, with planned extension into dermatological diseases.
Recent patents assigned to Brilacidin include: a patent covering Brilacidin oral, buccal and sublingual pharmaceutical compositions, including liquid compositions, such as rinses; a patent covering Brilacidin in combination with additional medicaments, such as antibiotics, anti-inflammatory agents, etc.
“As the Company prepares to advance Brilacidin into Phase 3 development for the prevention and treatment of oral mucositis, initially in Head and Neck Cancer, this new patent provides additional key protections,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals.
“Oral mucositis represents a large area of unmet need and a substantial market opportunity. We, along with potential Pharma partners, feel Brilacidin—as a conveniently-administered oral rinse—is well-positioned possibly to emerge one day as a frontline, go-to treatment for this common, costly and debilitating side-effect of chemoradiation.”
There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (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 on a worldwide basis, ~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.
Source: Company Press Release