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Tonix Pharmaceuticals Presents Phase 1 Formulation Development Data for TNX-601 CR in a Poster Presentation at CNS Summit 2021
Phase 2 Trial of TNX-601 CR for the Treatment of Major Depressive Disorder Expected to Start First Half 2022 CHATHAM, N.J., Nov. 09, 2021 (GLOBE NEWSWIRE) --
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Phase 2 Trial of TNX-601 CR for the Treatment of Major Depressive Disorder Expected to Start First Half 2022\nCHATHAM, N.J., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a poster presentation of results from its open-label, Phase 1 clinical study of TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets). Tonix is developing TNX-601 CR as a potential treatment for major depressive disorder (MDD) as well as post-traumatic stress disorder and neurocognitive dysfunction associated with corticosteroid use. A copy of the poster is available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com. CNS Summit 2021 is taking place November 7th – 10th in Boston, Mass. The poster presentations by Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, took place on November 8th and will also be presented on November 9th from 5:00 pm – 7:00 pm ET. The poster, titled, “TNX-601 CR*: a Once-Daily Formulation of Tianeptine in Development for the Treatment of Major Depressive Disorder” provides data related to the Phase 1 pharmacokinetic study in healthy subjects that assessed several novel modified-release (MR) prototype formulations of tianeptine oxalate. The study showed that the selected TNX-601 MR1 demonstrated pharmacokinetics appropriate for once-daily dosing with minimal food effect, which is a potential treatment adherence advantage over three times per day dosing of immediate release tianeptine sodium. This MR prototype was selected in the development of the final formulation of TNX-601 CR as a once-daily treatment for MDD. “We believe that these Phase 1 findings support our upcoming Phase 2 study of once-daily TNX-601 CR for MDD that we expect to initiate in the first half of 2022,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Tianeptine products have been approved in Europe and other countries around the world and marketed as prescription drugs for the treatment of depression for more than three decades. Based on our Phase 1 results, we believe that with respect to plasma tianeptine and its primary metabolite, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate releas...