Tonix is a research and development company that is focused on identifying promising new product candidates and advancing them through clinical development toward regulatory approval.
Tonix is currently focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense through potential medical counter-measures.
Tonix has two development programs focusing on PTSD. TNX-102 SL, or Tonmya®*, Tonix's lead product candidate, is designed as a bedtime treatment for PTSD and has been designated by the FDA as a Breakthrough Therapy. Tonmya is in Phase 3 development, having previously completed the Phase 2 AtEase study in 2016. In July 2018, the Phase 3 HONOR study of Tonmya in military-related PTSD was stopped early due to inadequate separation from placebo as measured by the primary endpoint at Week 12. However, meaningful improvement in overall PTSD symptoms was observed at Week 4. Additionally, a retrospective analysis of a subgroup with trauma ≤9 years from screening showed a clinically meaningful response as measured by the primary endpoint at Week 12. The Company will meet with the FDA in October 2018 to discuss a new Phase 3 study of Tonmya using a modified trial design. A pivotal efficacy study may initiate as early as 2019.
TNX-601 (tianeptine oxalate), designed as a daytime treatment for PTSD, 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.
TNX-102 SL, the same drug product as Tonmya, is a potential bedtime treatment for agitation in Alzheimer’s disease (AAD). The FDA has designated it a Fast Track development program. The effective IND has sufficient data to support a Phase 2 potential pivotal efficacy study in Alzheimer’s disease patients with agitation. AAD is another condition where sleep disturbances are also considered to play a central role in the pathophysiology. Currently, there are no FDA-approved treatments for AAD, despite a high disease burden and a need for an effective therapy.
Tonix has two pre-IND programs that are focused on biodefense technologies.
TNX-801 is a potential smallpox preventing vaccine containing a live synthetic version of horsepox virus. TNX-801 has unique properties that Tonix believes may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines. The licensure of TNX-801 may be qualified for Priority Review Voucher under the Medical Countermeasure incentive provided by the 21st Century Cures Act.
TNX-701 is a biodefense technology relating to the development of protective agents against radiation exposure. Tonix has begun nonclinical research and development on TNX-701 and plans to develop it under the Animal Efficacy Rule.
There is growing recognition that there is a constellation of disorders where sleep disturbances may have a role in the pathophysiology (psychiatry, chronic pain, and neurology). TNX-102 SL, by improving sleep quality, may offer not only therapeutic benefit but a unique approach to treating some of these disorders. Tonix will consider life-cycle opportunities for TNX-102 SL as the clinical development progresses.
Our experienced team has a strong track record of success in drug development, regulatory approvals, and product launch activities.
Tonix relies on the broad pharmaceutical and scientific experience of its management team, board of directors and scientific advisors to advance product candidates through the development process.
*Tonmya has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.