The Supply and License Agreement provides for the supply of specially formulated capsules of SUBA-Itraconazole, manufactured by Mayne Pharma under cGMP (current good manufacturing practice) standards, for use by us in our planned clinical trials for late-stage prostate and lung cancers, and for the future exclusive commercial supply following FDA approvals, if obtained.
“SUBA” technology (which stands for “super bioavailability”) is designed to improve the bioavailability of orally administered drugs that are poorly soluble. SUBA-Itraconazole is a patented formulation developed by Mayne Pharma, which has improved absorption and significantly reduced variability compared to generic itraconazole. These benefits are intended to provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical dose response and a reduction in the amount of active drug required to deliver therapeutic blood levels.
INHIBITOR completed a Phase 2b trial testing SUBA-Itraconazole for the treatment of basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) and transferred the program to Mayne Pharma which is planning to begin a global Phase 3 trial during 2020.