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Tonix Pharmaceuticals Announces Trial Design of New Phase 2 Clinical Study of TNX-1300 for Cocaine Intoxication
New Trial Design is Single-Blind, Placebo-Controlled, Potential Pivotal Study, Pending FDA Agreement Expected to Include Women Based on Reproductive
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"New Trial Design is Single-Blind, Placebo-Controlled, Potential Pivotal Study, Pending FDA Agreement Expected to Include Women Based on Reproductive Toxicology Studies, Pending FDA Agreement Planning to Include Patients Who Have Received Naloxone to Increase Enrollment CHATHAM, N.J., June 27, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the design of a new Phase 2 clinical trial of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of cocaine intoxication. This new protocol has the potential to serve as a pivotal trial. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine in cocaine users, as demonstrated in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study, providing support of the use of TNX-1300 as a treatment for cocaine intoxication.1 The Company plans to submit the new protocol to the U.S. Food and Drug Administration (FDA). A positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been previously completed. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. As a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in addition to expected patent protection through 2029. “The design of the new Phase 2 trial has the potential to serve as a pivotal trial,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are approximately 505,000 emergency room visits annually involving cocaine use, with approximately 61,000 of the visits involving detox services to treat cocaine overdose. In 2020, about 19,447 overdose deaths involving cocaine occurred in the U.S.2 We believe that TNX-1300 has the potential to be a new treatment option for the substantial morbidity and mortality caused by cocaine intoxication.” “The new study replaces the Phase 2 open-label trial with TNX-1300 for cocaine intoxication originally expected to start in the second quarter of 2022, which was designed to evaluate feasibility of enrollment,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We expect to be able to include women in this study, pending FDA agreement, since w...