Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) 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). This randomized, double-blind, placebo-controlled study aims 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 a critical role in MDD. The therapy is already approved by the FDA under the brand name TONMYA™ for the treatment of fibromyalgia in adults. Tonix noted that TNX-102 SL has previously shown signals for improving depressive symptoms and subjective sleep quality in earlier clinical studies. The company is also developing the therapy for several additional indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder, and agitation in Alzheimer’s disease.
Major depressive disorder is a common and serious medical illness that negatively affects how people feel, think, and act. According to the World Health Organization, more than 264 million people worldwide suffer from depression. Current treatments often have limited efficacy and significant side effects, highlighting the need for new therapeutic options. If successful, TNX-102 SL could provide a novel first-line monotherapy that addresses both depressive symptoms and sleep disturbances, potentially improving outcomes for patients.
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 company’s recently approved flagship medicine and 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®.
The company 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, Tonix’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.
For more information on Tonix Pharmaceuticals and its pipeline, visit the company’s newsroom at https://nnw.fm/TNXP. The full press release is available at https://nnw.fm/dORql.
