Radiation-induced severe oral mucositis (SOM)
Our leading drug candidate, IZN-6N4, is designed to prevent and treat SOM in head and neck cancer patients. SOM, which occurs in about 70% of these patients, comprises the painful and debilitating ulcerated sores that develop in the mouth and throat of radiation therapy patients. IZN-6N4 has shown strong efficacy in preventing the incidence of SOM and reducing undesirable side effects in its completed Phase II trial, and Izun anticipates initiating its Phase III trial in the second half of 2021. Currently, there are no approved drugs for the prevention of SOM, a potential $0.5 billion market.
Chemotherapy-induced OM
Prevention of Chemotherapy-Induced OM is planned to be the second target indication for IZN-6N4. Chemotherapy treatment causes SOM in 35% of patients. IZN-6N4, initially tested on head & neck cancer patients, will enter trials to expand its use to the prevention of SOM for the full range of chemotherapy treatments. IZN-6N4 is well suited for these indications due to its efficacy and ease of administration.
Breast-cancer associated VVA
Over 80% of breast cancer patients receive hormone-reduction therapy during treatment and continue this regimen for a 5-year maintenance period. For a significant percentage of patients, this therapy results in severe Vulvovaginal Atrophy (VVA), with associated pain, increased infections and painful intercourse. IZN-6NVS demonstrated in a Phase IIa trial a highly significant reduction of all symptoms of VVA. A Phase IIb trial is planned for 2022.
Chemotherapy-induced nausea and vomiting (CINV)
Izun has combined an approved drug for CINV with its innovative and performance-enhancing drug-delivery system to improve the treatment for this indication. The FDA has cleared this product for clinical trials under a 505(b)(2) regulatory track which reduces the need for extensive clinical trials. Downstream, this unique delivery system will also be utilized for additional indications, such as refractory pain, in oncology patients.