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Tonix Pharmaceuticals Receives Federal Grant from the National Institute on Drug Abuse (NIDA) to Advance Development of TNX-1300 as a Treatment for Cocaine Intoxication
There is No FDA-Approved Product for Cocaine Intoxication TNX-1300 Has Been Granted Breakthrough Therapy Designation by the FDA Phase 2 Single-Blind,
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"There is No FDA-Approved Product for Cocaine Intoxication TNX-1300 Has Been Granted Breakthrough Therapy Designation by the FDA Phase 2 Single-Blind, Placebo-Controlled, Potential Pivotal Study Expected to Start in Fourth Quarter 2022, Pending FDA Agreement CHATHAM, N.J., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine. Cocaine intoxication refers to a state in which cocaine has deleterious effects on several body systems, especially the cardiovascular system. TNX-1300 demonstrated activity on reversing the physiological effects of i.v. cocaine challenge in people who use cocaine in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study.1 The grant is intended to support continued development of TNX-1300 as a treatment for life threatening cocaine intoxication. In 2021, more than 24,900 individuals in the U.S. died from drug overdose deaths involving cocaine2. “This grant award underscores the unmet need for safe and effective treatments for cocaine intoxication and validates the progress we have achieved to date with TNX-1300,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Cocaine intoxication remains a serious issue in the U.S. where there is currently no specific pharmacotherapy indicated treatments. By targeting the cause rather than the symptoms of cocaine intoxication, we believe TNX-1300 may offer significant advantages to the current standard of care for cocaine intoxication.” Tonix recently announced the design of a new single-blind, open-label, placebo-controlled, randomized Phase 2 clinical trial of TNX-1300 for the treatment of cocaine intoxication. The Phase 2 study, which has the potential to serve as a pivotal trial, is anticipated to start in the fourth quarter of 2022, pending U.S. Food and Drug Administration (FDA) agreement. TNX-1300 has been granted Brea...