Tonix Pharmaceuticals (NASDAQ: TNXP) announced 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, and 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 and is also being developed for several additional indications, including post-traumatic stress disorder, Long COVID, alcohol use disorder and agitation in Alzheimer’s disease.
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