With the company approaching next week's final patient follow-up visit and the conclusion of its Phase 2 trial of Brilacidin as a promising preventative treatment for Oral Mucositis (OM) (see NCT02324335 and the highly encouraging interim results), we thought it appropriate to share some data on the overall OM market opportunity.
A large unmet need exists in treating OM as discussed in earlier blogs, accessible here and here. There is no approved preventive or curative treatment for OM. Current treatments for OM, and most therapies in clinical trials, are largely palliative in nature, with few interventions showing clinical benefit. The most common management protocol for OM is the use of mouthwash or gels.
In December 2004, the FDA approved Amgen’s IV-administered Kepivance (palifermin) for the treatment of OM limited to bone marrow cancers. In the primary efficacy study, the median duration of OM (WHO grade 3 and 4) was shorter (three days vs. nine days) in patients receiving palifermin.
Head and Neck Cancer (HNC) patients -- comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN) -- are at greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM during the course of their chemo/radiotherapy.
Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually.
The completion of Innovation Pharmaceutical’s Phase 2 study of Brilacidin-OM will mark an important step towards the company’s goal of potentially developing the first-ever preventative treatment for OM.
Reporting of topline results is anticipated to occur this quarter.