Tonix updates enrollment in Phase 2 UPLIFT Study of TNX-601 ER for MDD

Tonix Pharmaceutical announced that development of TNX-4300 or estianeptine, the single -isomer of tianeptine will be prioritized over TNX-601 ER, which is being studied in the Phase 2 UPLIFT1 trial for the treatment of major depressive disorder MDD. TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. Recent findings have shown estianeptine possesses the ability to improve memory and cognition in vivo as measured in the rat Novel Object Recognition test, and the ability to restore neuroplasticity to neurons in cell culture. The finding that estianeptine is responsible for improving memory and cognition in vivo suggests a role for peroxisome proliferator-activated receptor PPAR-ss/d activation in memory. For these reasons, Tonix intends to accelerate completion of enrollment for the Phase 2 UPLIFT1 trial to reallocate resources to the preclinical development of TNX-4300 and now expects to report topline data from this study in the fourth quarter of 2023. Tonix is also accelerating completion of enrollment in the RESILIENT study of TNX-102 SL for the management of fibromyalgia so that approximately 450 patients will be enrolled, and topline results are expected in the fourth quarter of 2023. Tonix has filed patents claiming single (S)-isomer estianeptine, the active ingredient in TNX-4300, which is devoid of activity on the micro-opioid receptor in tissue culture. Tonix has filed patent claims that describe crystalline salt forms of estianeptine that appear well suited to formulation. TNX-4300 is currently in preclinical development for depression, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease. Key experiments were performed by scientists at Tonix’s Research and Development Center (RDC) in Frederick, Maryland. TNX-601 ER and TNX-4300 are investigational new drugs and are not approved for any indication. TNX-601 ER is being developed under an IND. TNX-4300 is at the pre-IND stage of development.