Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced today 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 drug is also being developed 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 for Tonix as it seeks to expand the utility of TNX-102 SL beyond fibromyalgia. Major depressive disorder is a common and serious medical illness that negatively affects how a person feels, thinks, and acts. According to the National Institute of Mental Health, an estimated 21 million adults in the United States had at least one major depressive episode in 2020. Current treatment options, including selective serotonin reuptake inhibitors and other antidepressants, often have delayed onset of action and limited efficacy, highlighting the need for novel therapies.
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®. 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. The company 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, visit the company’s newsroom at https://nnw.fm/TNXP.
