Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced that the first patient has been enrolled in the HORIZON Phase 2 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. The therapy is already approved by the FDA under the brand name TONMYA(TM) 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 is a critical step for Tonix as it seeks to expand the use of TNX-102 SL beyond fibromyalgia. Major depressive disorder affects millions of people worldwide, and many patients do not achieve adequate response with current treatments. If successful, TNX-102 SL could offer a new first-line option that targets sleep disturbance, a common and often overlooked symptom of MDD. The study’s focus on sleep quality as a mechanism of action differentiates it from conventional antidepressants, which primarily target neurotransmitter systems.
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(TM) (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(R) SymTouch(R) and Tosymra(R). 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 marks a milestone for the HORIZON trial, and investors will be watching for top-line data expected in the coming months. The outcome could have significant implications for Tonix’s stock and for the broader MDD treatment landscape.
