Oral Mucositis (OM) is a painful inflammation and ulceration of the mucous membranes lining the mouth, usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer. As a result of cell death in reaction to chemo- or radio-therapy, the mucosal lining of the mouth becomes thin, red, inflamed and ulcerated. Patients undergoing chemo- or radio-therapy usually become symptomatic one to two weeks after beginning treatment, with more severe tissue damage typically leading to increased pain. In addition, infection of sores and ulcers by viruses, bacteria and fungi leads to further induction of inflammation, exacerbating tissue damage and pain.
An estimated 700,000 head and neck cancer (HNC) patients worldwide are at greatest risk of developing OM, with a staggering 90% to 100% of HNC patients developing OM. By 2030, the global incidence of HNC cases is expected to exceed one million per year. Moreover, between 25% and 60% of cancer patients, regardless of type, will experience OM at some point during the course of their therapy.
Current treatments for OM and most therapies in active 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. Estimates vary as to the total market size of an effective OM treatment. For HNC patients in the U.S., Europe, and Japan alone, the estimated market size ranges from $500 million to $1.5 billion annually.
Lakewood-Amedex plans to initiate a placebo-controlled, dose escalating Phase 1 clinical trial evaluating oral tolerability to Nu-3 applied topically in healthy volunteers in Q3 2019. A Phase 2a study in patients with OM is expected to begin in H1 2020 with top-line data expected by Q3 2020.