Tonix Pharmaceuticals has enrolled the first participant in the Phase II ‘UPLIFT’ trial of TNX-601 ER (tianeptine hemioxalate extended-release tablets) to treat major depressive disorder (MDD).
The randomised, placebo-controlled, double-blind, multicentre Phase II UPLIFT study, TNX-TI-M201, has been designed to asses the safety and efficacy of TNX-601 ER taken orally, once-a-day, for six weeks to treat MDD.
A total of 300 adult patients aged 18 to 65 years, with a DSM-5 depression diagnosis and a current major depressive episode (MDE) with a duration of at least 12 weeks, are planned to be enrolled at nearly 30 sites across the US.
They will be randomised into a 1:1 ratio into a TNX-601 ER 39.4mg arm and a placebo arm.
Mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline at week six is the trial’s primary efficacy endpoint.
The Sheehan Disability Scale (SDS) and the Clinical Global Impression of Severity Scale (CGI-S) are some of the important secondary efficacy endpoints of the trial.
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The company expects to receive data from a planned interim analysis in the fourth quarter of this year.
Tonix Pharmaceuticals chief medical officer Gregory Sullivan said: “After a decade of development of our proprietary, once-daily tianeptine formulation, it is very gratifying to enter the next stage of clinical testing required to make TNX-601 ER available to those suffering from MDD in the US.
“TNX-601 ER not only has the potential to relieve depressive symptoms, but also to improve the quality of life and resiliency for the millions of MDD sufferers.
“The short and long-term safety of tianeptine sodium IR has been well-established, based on its clinical use outside the US.”