On the Unmet Medical Need in Oral Mucositis: Brilacidin as a Potential First-in-Class Preventative Treatment

Oral Mucositis (OM) is a frequent complication of chemoradiation in head and neck cancer patients. Symptoms include painful and debilitating inflammation and ulceration, which increases a sufferer’s susceptibility to bacterial infections. Patients often are unable to speak or eat, requiring the insertion of feeding tubes and other dietary support. The condition also can lead to a reduction, or even cessation, of radiation and chemotherapy for cancer treatment. Severe cases may require hospitalization, resulting in higher costs ($17,000 or more per patient).

Current treatments for OM, and most in clinical trials, are largely palliative in nature, with few interventions (pdf) showing statistically-validated clinical benefit. As this recent, May 1, 2017, article noted: “No pharmacotherapies are currently approved by the FDA to treat OM, and no gold standard for treatment exists.”

It is in this therapeutic context—the huge unmet need in the OM patient population, which is estimated to be as large as 500,000 in the U.S. alone—that Cellceutix is advancing Brilacidin, its novel immunomodulatory drug candidate in mid-phase testing being evaluated across various indications. Awarded Fast Track designation by the FDA in November 2015, Brilacidin has the potential to become a first-in-class treatment for OM by not only reducing, but actually preventing, severe OM.

As previously released interim results showed, based on the ongoing, Phase 2 multi-center, randomized, double-blind, placebo-controlled study (see NCT02324335), Innovation is enthusiastic about Brilacidin’s treatment potential in preventing OM. The Company looks forward to continuing to share additional results as they become available.