Tonix Pharmaceuticals is currently enrolling participants in a Phase 3 trial for posttraumatic stress disorder (PTSD). For more information, please visit www.recoverystudy.com or www.clinicaltrials.gov (NCT03841773).
PTSD is a prevalent global disorder in which individuals experience a prolonged maladaptive response following exposure to life-threatening or severely injurious trauma (sexual and physical assault, natural disasters, combat, and accidents).
TNX-601, is a novel proprietary oral formulation of tianeptine oxalate.
Tianeptine oxalate is a novel polymorph and salt of tianeptine, discovered and characterized by Tonix to improve stability, consistency and manufacturability;
Tianeptine sodium (trade names Stablon® and Coaxil®) has an established safety profile based on its decades of use as an antidepressant in many European, Asian, and Latin American countries, but has never been approved for any indication in the U.S. Several published studies support the potential of tianeptine as a possible effective and safe therapy for patients with PTSD.1,2,3,4
Like cyclobenzaprine, tianeptine shares structural similarities with classic tricyclic antidepressants, but it has unique pharmacological and neurochemical properties.5 Tianeptine modulates the glutamatergic system indirectly and reverses the inhibitory neuroplasticity observed during periods of stress and steroid use. It is a weak mu-opioid receptor (MOR) agonist but does not have significant affinity for known neurotransmitter receptors.
Leveraging Tonix's development expertise in PTSD, TNX-601 is being developed as a first line monotherapy for PTSD for daytime dosing. Tianeptine's reported pro-cognitive and anxiolytic effects as well as its ability to reduce excessive stress responses suggest that it can be used to treat PTSD by a different mechanism of action than Tonmya.5
TNX-601 is currently at the pre-IND stage as a potential daytime treatment for PTSD. An IND-enabling study is underway with preliminary human pharmacokinetic and safety data (non-IND study) expected in the second half of 2019.
Tonix has filed a patent for the novel salt polymorph related to TNX-601. A patent has been issued related to the use of TNX-601 for steroid-induced cognitive impairment and memory loss. These patents are owned outright by Tonix Pharmaceuticals, with no obligations owed to another party.