Tonix Pharmaceuticals Enrolls First Patient in Phase 2 Depression Trial, Targeting Major Depressive Disorder with TNX-102 SL

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the enrollment of the first patient in its Phase 2 HORIZON clinical trial, evaluating TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder (MDD). This randomized, double-blind, placebo-controlled study is expected to enroll approximately 360 patients at about 30 U.S. sites. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after six weeks of treatment, with secondary measures including sleep quality, anxiety, and global clinical improvement.

TNX-102 SL, already FDA-approved under the brand name TONMYA™ for fibromyalgia in adults, is designed to improve sleep quality, which Tonix believes plays a crucial role in MDD. The drug has previously shown signals for improving depressive symptoms and subjective sleep quality in earlier clinical studies. This trial represents a significant step in exploring the drug's potential beyond fibromyalgia, as the company also develops it for post-traumatic stress disorder, Long COVID, alcohol use disorder, and agitation in Alzheimer's disease.

The importance of this announcement lies in the unmet need for effective MDD treatments with novel mechanisms. Current first-line therapies often have delayed onset or side effects, and TNX-102 SL's focus on sleep disruption—a common symptom in depression—may offer a differentiated approach. If successful, TNX-102 SL could provide a new option for patients who do not respond adequately to existing antidepressants. The full press release is available at https://nnw.fm/dORql.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. The company’s CNS commercial infrastructure supports its marketed products, including acute migraine treatments Zembrace® SymTouch® and Tosymra®. Beyond MDD, Tonix's pipeline includes TNX-2900 for Prader-Willi syndrome, monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500 for kidney transplant rejection prevention. The company's product development candidates remain investigational, and their efficacy and safety have not been established for any indication outside approved uses.

For ongoing updates, visit Tonix's newsroom at https://nnw.fm/TNXP.