Tonix Pharmaceuticals announces data on TNX-601 ER, TNX-4300

Tonix Pharmaceuticals announced data supporting the memory- and cognition-enhancing effects of two Tonix drug candidates, TNX-601 ER and TNX-4300, the single-isomer of tianeptine. TNX-601 ER is being tested in the potentially pivotal Phase 2 UPLIFT1 trial for the treatment of major depressive disorder, with topline results expected in the first quarter of 2024. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. The findings reported show that tianeptine and estianeptine improve memory and cognition as measured in the rat Novel Object Recognition test. The finding that estianeptine is responsible for improving memory and cognition suggests a role for PPAR-beta/delta activation in memory. “The memory- and cognition-enhancing effects of racemic tianeptine and estianeptine seen in the NOR test are consistent with human clinical studies in which racemic tianeptine treatment improved cognition and memory in patients with Alzheimer’s disease and depression6 and in patients with bipolar disorder,7” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We recently reported that estianeptine induces neuroplasticity in cell culture.2 The new findings indicate that estianeptine also improves memory and cognition in the in vivo rat NOR test. We believe that together these findings support the development of tianeptine and estianeptine in psychiatric and neurodegenerative diseases. Tianeptine’s ability to restore atrophied neuronal connections in animals2 suggests the potential to achieve durable outcomes.”