A recent online article published by Baystreet.ca, in follow-up to an earlier one, similarly places Brilacidin-OM in a leading competitive position as multiple pharmaceutical companies look to obtain the first-ever marketing approval for a drug to treat Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
The article characterizes Brilacidin-OM as a potential “category creator” in the OM space -- estimated to be approximately a $1 billion annual market opportunity -- with direct comparisons to how Merck and Glaxo successfully pioneered two drug to address untapped indications.
Innovation Pharmaceuticals has completed a randomized, double-blind Phase 2 Trial of Brilacidin-OM (see NCT02324335), with topline results publicly released.
The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of SOM (WHO Grade ≥ 3) compared to placebo. Two key secondary endpoints in the trial, delaying the onset of SOM and reducing the duration of SOM, were met. Further subgroup analysis also showed Brilacidin-OM was particularly effective in decreasing the incidence of SOM in HNC patients receiving the more aggressive chemotherapy regimen.
Brilacidin-OM is being developed under FDA Fast Track Designation.