Tonix Pharmaceuticals Enrolls First Patient in Phase 2 Trial of TNX-102 SL for Major Depressive Disorder
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced that the first patient has been enrolled in the HORIZON Phase 2 clinical trial evaluating TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder (MDD). The randomized, double-blind, placebo-controlled study is expected to enroll approximately 360 patients at about 30 U.S. sites. The trial will assess changes in depression severity after six weeks of treatment, along with measures of sleep quality, anxiety and global clinical improvement.
TNX-102 SL is designed to improve sleep quality, which the company believes plays an important role in MDD. The therapy is already approved by the FDA under the brand name TONMYA™ for the treatment of fibromyalgia in adults. Tonix said the therapy has previously shown signals for improving depressive symptoms and subjective sleep quality in earlier clinical studies. The company is also developing TNX-102 SL for several additional indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder and agitation in Alzheimer’s disease.
The HORIZON trial marks a significant step in exploring the potential of TNX-102 SL beyond fibromyalgia. According to the press release, the full details are 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 in areas of high unmet medical need. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the first new treatment for fibromyalgia in more than 15 years.
The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
The enrollment of the first patient in the HORIZON trial highlights Tonix’s commitment to addressing unmet needs in CNS disorders. Major depressive disorder affects millions of adults worldwide, and current treatments often have limited efficacy or significant side effects. By targeting sleep quality as a key component of MDD, TNX-102 SL offers a novel approach that could differentiate it from existing antidepressants. If successful, this therapy could provide a new option for patients who do not respond adequately to current first-line treatments.
Investors and industry observers will be watching the trial’s progress closely. For the latest news and updates relating to TNXP, the company’s newsroom is available at https://nnw.fm/TNXP. The implications of this trial extend beyond MDD; positive results could also bolster development for other indications such as PTSD and Long COVID, which similarly involve sleep disturbances. As the study progresses, data on safety and efficacy will be critical in determining whether TNX-102 SL can become a new standard of care for depression.
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