Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the enrollment of the first patient in the HORIZON Phase 2 trial, a randomized, double-blind, placebo-controlled study evaluating TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder (MDD). The 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 initiation of this Phase 2 trial marks a significant step in addressing the high unmet medical need in MDD, a condition that affects more than 21 million adults in the United States. Current first-line treatments often have limited efficacy and significant side effects, leaving many patients without adequate relief. TNX-102 SL, with its novel mechanism targeting sleep disturbance, could offer a new approach for patients who have not responded to standard antidepressants.
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).
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.
The full press release is available at https://nnw.fm/dORql. For more information about Tonix Pharmaceuticals, visit their newsroom at https://nnw.fm/TNXP.
