c-Myc x CD47 x NLRP3

FDA also accepts company's Investigational New Drug (IND) application to initiate a follow-on phase 2b clinical trial, called KEVLARx 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. About RRx-001 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. About EpicentRx 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. SOURCE EpicentRx, Inc.

The funding will support study of lead small molecule inflammasome inhibitor in MND, also known as amyotrophic lateral sclerosis (ALS) TORREY PINES, Calif. and QUEENSLAND, Australia, Nov. 29, 2022 /PRNewswire/ -- EpicentRx Inc. ("EpicentRx"), a late-stage biopharmaceutical company with platforms that treat and target multiple immune-mediated inflammatory disorders, and FightMND, Australia's largest independent funder of research in motor neuron disease (MND), are pleased to announce that EpicentRx has been awarded funding from FightMND to evaluate the potential neuroprotective benefits of the company's lead small molecule, RRx-001. RRx-001, a direct NLRP3 inflammasome inhibitor, will be evaluated as a novel disease modifying therapy for MND. This announcement follows a recent $500,000 grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF), to study the potential therapeutic effects of RRx-001 in Parkinson's disease (PD), with groundbreaking early data presented at the annual Neuroscience 2022 conference in San Diego earlier this month. The prestigious FightMND funding, which is a highly competitive award, will continue the organization's efforts to support innovative research focused on improving or fast-tracking the translation of effective treatments through to clinical trials for MND. The research program on RRx-001 will be led by Associate Professor Richard Gordon at the Queensland University of Technology's (QUT) Translational Research Institute and Centre for Microbiome Research (CMR) in Brisbane, Australia. Dr Gordon also leads the MJFF research program on PD, with co-funding from Shake it Up Australia, a not-for-profit organization dedicated to finding a cure for PD. Dr. Gordon is an expert on Parkinson's disease, neuroinflammation and inflammasome activation in the Central Nervous System (CNS). The RRx-001 MND program will also include experienced neurologists from the Royal Brisbane and Women's Hospital, Professor Pam McCombe and A/Prof. Rob Henderson. RRx-001, the lead compound of EpicentRx's CyNRGY platform of small molecules, is currently in a Phase 3 clinical trial for small cell lung cancer (SCLC). RRx-001 binds selectively to immune and red blood cells and triggers protective cellular responses through induction of the Nrf2 pathway and inhibition of the NLRP3 inflammasome. The protective pathways induced by RRx-001 through inflammasome inhibition and Nrf2 activation support a new synergistic mechanism of neuroprotection in the brain, blood/vascular and immune system which are affected in PD. "We are very pleased to receive this support from FightMND and share their mission to finding effective treatments for neurodegenerative diseases such as MND," said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx. "This funding is vital to broadening our understanding of how RRx-001's inhibition of the inflammasome may change the course of treatment and prevention of chronic inflammation-driven diseases such as Parkinson's and MND." "We are excited to be partnering with EpicentRx and FightMND to develop RRx-001 as a new treatment since it targets multiple mechanisms involved in MND pathology" said Dr Richard Gordon. "By targeting multiple mechanisms with the same drug, we will maximize our chances of being able to slow or halt MND progression in the clinic" FightMND has invested nearly $70 million into vital MND research since 2014. About EpicentRx Inc. EpicentRx is a leading-edge 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 . SOURCE EpicentRx, Inc.