Tonix Pharmaceuticals initiates enrollment in Phase 2 UPLIFT study

Tonix Pharmaceuticals announced that the first participant was enrolled in the Phase 2 ‘UPLIFT’ study of TNX-601 ER1 for the treatment of major depressive disorder, MDD. The double-blind, placebo-controlled registrational-quality study has a target enrollment of 300 participants at approximately 30 sites across the U.S. Results from a planned interim analysis are expected to be released in the fourth quarter of 2023. "Despite the availability of several classes of MDD treatments in the U.S. that directly modulate neurotransmitters and their synaptic receptors, there remains an unmet need for novel approaches," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "In animal studies, TNX-601 ER has a unique mechanism of action that restores brain neuroplasticity by exerting biological effects on neurons and glial cells that increase arborization of dendrites in critical hippocampal circuits.2 In animal models, tianeptine also reverses stress-induced impairments in synaptic glutamate neurotransmission, and it restores hippocampal neurogenesis.2"