On March 16, 2023 Modra Pharmaceuticals ("Modra") reported that the U.S. Patent and Trademark Office (USPTO) has issued to Modra U.S. Patent No. 11,571,408, covering the use of its oral taxane therapeutic ModraDoc006/r (Press release, Modra Pharmaceuticals, MAR 16, 2023, View Source [SID1234628904]). ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent that enhances bioavailability. ModraDoc006/r has been designed to be an effective anti-cancer therapeutic which can be taken at home and which eliminates or reduces serious, treatment-limiting side effects. The patent provides protection for ModraDoc006/r until 2039.

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"In clinical testing to date, ModraDoc006/r has demonstrated an attractive efficacy profile while avoiding levels of neutropenia, anemia, alopecia and peripheral neuropathy that are common with IV administration of docetaxel chemotherapy," said Colin Freund, CEO of Modra Pharmaceuticals. "The grant of this patent by the USPTO, which significantly extends our patent coverage until 2039, is a validation of our differentiated approach and underscores our commitment to bringing safer and more convenient treatment options to cancer patients."

The patent covers the use of Modra’s compound, ModraDoc006, an oral formulation of docetaxel, at doses which control side effects by preventing elevated peak plasma levels of docetaxel, while maintaining an effective plasma level of docetaxel to eradicate tumor cells. High peak plasma levels (and consequent higher toxicities) are a consequence of the IV administration of docetaxel, which historically has been widely used as a chemotherapy for many types of solid tumors.

The company announced the results from its Phase 2b trial with ModraDoc006/r in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) in mid-2022. ModraDoc006/r demonstrated a significantly improved safety profile compared to standard-of-care IV chemotherapy docetaxel at 75 mg/m2 Q3W. Based on the results, Modra is planning for a Phase 3 pivotal trial in mCRPC patients.