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 U.S. Food and Drug Administration (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. In addition to MDD, TNX-102 SL is being developed for several other indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder and agitation in Alzheimer’s disease.
The initiation of this trial marks a significant step for Tonix Pharmaceuticals as it seeks to expand the therapeutic applications of TNX-102 SL beyond fibromyalgia. Major depressive disorder affects millions of Americans, and current treatments often have limited efficacy or significant side effects. By targeting sleep disturbances, which are common in MDD, TNX-102 SL could offer a novel approach that addresses both depressive symptoms and sleep quality.
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. The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products Zembrace® SymTouch® and Tosymra®.
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 about the company and its pipeline, visit the Tonix Pharmaceuticals newsroom.
The success of the HORIZON trial could have significant implications for the treatment of MDD, potentially providing a new first-line monotherapy that improves sleep quality as a core component of depression management. The trial’s results are anticipated to inform future development and regulatory strategies for TNX-102 SL in MDD.
