Tonix is developing innovative pharmaceutical products to address emerging public health issues, with two programs focusing on posttraumatic stress disorder (PTSD). TNX-102 SL is ready to start Phase 3 and TNX-601 is in preclinical development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD and overall high utilization of healthcare services creating significant economic burden. Other development efforts include a smallpox-preventing vaccine program.
The development of TNX-102 SL in PTSD is supported by both clinical and mechanistic rationales. In May 2016, Tonix announced positive topline results from a Phase 2 study, referred to as AtEase, investigating the efficacy and safety of TNX-102 SL in military-related PTSD. To prepare for the Phase 3 program and seek guidance on the New Drug Application (NDA) plan, Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA in the third quarter of 2016. In December 2016, TNX-102 SL received Breakthrough Therapy designation by the FDA for the treatment of PTSD. Tonix plans to begin enrolling patients into its first Phase 3 study, the HONOR study, in the first quarter of 2017 after receiving FDA agreement on the study design and interim analysis plan.
Tonix’s other PTSD program, TNX-601, is an oral formulation of tianeptine for which Tonix has discovered and characterized a novel polymorph and salt. Tianeptine sodium (amorphous) is marketed for depression in Europe, Asia, Latin America – first approved in France in 1987. The clinical development of TNX-601 for PTSD can leverage the post-marketing experience of tianeptine outside the U.S.
Other Development Programs
TNX-801 is a live novel virus vaccine with the potential to prevent smallpox. Since TNX-801 will be developed for a "serious or life-threatening condition caused by exposure to lethal or permanently disabling toxic biological” , Tonix believes the “Animal Efficacy Rule” is applicable. The Animal Efficacy Rule ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. In addition, the approval of TNX-801 may be qualified for Priority Review Voucher under the Medical Countermeasure (MCM) incentive provided by the 21st Century Cures Act.
Our experienced team has a strong track record of success in drug development, regulatory approvals, and product launch activities.
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication.