Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has announced the enrollment of the first patient 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 and 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, and 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 and is also being developed for several additional indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder and agitation in Alzheimer’s disease.
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), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’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.
This development is significant because MDD affects millions worldwide, and current treatments often have limited efficacy or tolerability issues. TNX-102 SL, if successful, could offer a new first-line monotherapy option that addresses sleep disturbances, a common and debilitating symptom of depression. The trial’s progression marks a step forward in Tonix’s strategy to expand TONMYA’s indications beyond fibromyalgia.
For more information on Tonix Pharmaceuticals, visit https://nnw.fm/TNXP.
