The Food and Drug Administration (FDA) has granted Fast Track designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.
RRx-001 is an investigational small molecule inflammasome NLRP3 inhibitor and Nrf2 upregulator designed to protect healthy tissues by promoting antioxidant and anti-inflammatory properties. According to the Company, preliminary data suggest treatment with RRx-001 prior to common chemotherapeutics or radiation therapy resulted in less new malignancies, tumor recurrences, or adverse events (eg, severe oral mucositis, neutropenia).
The FDA has accepted the Investigational New Drug (IND) application for RRx-001 to initiate the phase 2b KEVLARx trial in head and neck cancer patients. The Company is also investigating RRx-001 for the treatment of small cell lung cancer, solid and CNS tumors, and neurodegenerative diseases.
“The Fast Track Designation is great news for EpicentRx, and it puts us one step closer to a potential treatment for this critical unmet need of oral mucositis with RRx-001,” said EpicentRx CEO, Dr Tony Reid.
- EpicentRx receives Fast Track designation from the US FDA for lead asset, RRx-001, to prevent/attenuate chemotherapy and radiation treatment induced severe oral mucositis. News release. EpicentRx. Accessed March 29, 2023. https://www.prnewswire.com/news-releases/epicentrx-receives-fast-track-designation-from-the-us-fda-for-lead-asset-rrx-001-to-preventattenuate-chemotherapy-and-radiation-treatment-induced-severe-oral-mucositis-301784214.html.
- Technologies: CyNRGY™ (RRx-001). EpicentRx. Accessed March 29, 2023. https://www.epicentrx.com/cynrgy-platorm/.