FDA also accepts company’s Investigational New Drug (IND) application to initiate a follow-on phase 2b clinical trial, called KEVLARx
TORREY PINES, CA, March 29, 2023 — EpicentRx, Inc. (“EpicentRx”), announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to RRx-001, a direct NLRP3 inhibitor and Nrf2 upregulator with anti-inflammatory and antioxidant properties, for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head & neck cancer patients. The FDA also accepted the company’s Investigational New Drug (IND) application to initiate a follow-on phase 2b clinical trial, called KEVLARx, in the same head & neck cancer patient population.
According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious or life-threatening conditions and fulfill an unmet medical need so that they reach approval, and patients, sooner. In this case, the unmet medical need is severe oral mucositis (SOM), for which no treatment is currently available. SOM is not only a debilitatingly painful side effect of chemotherapy and radiation, but it is also potentially life-threatening because of concomitant infections. The benefits of Fast Track Designation include a “rolling review” of completed sections of the New Drug Application (NDA), more frequent interaction with the FDA to expedite the review process, and potential eligibility for accelerated approval and priority review.
“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.
RRx-001 is a highly selective NLRP3 inhibitor under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and a planned Phase 2b trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a medical countermeasure for nuclear and radiological emergencies and as a treatment for neurodegenerative diseases like Parkinson’s and ALS/MND.
EpicentRx is a leading-edge clinical-stage biopharmaceutical company with a complementary pipeline of small molecules, novel drug delivery devices, and cancer selective virus platforms that target inflammatory diseases of significant unmet need. For more information visit www.epicentrx.com.
Dylan McNulty, Senior Account Coordinator, Taft Communications