Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) closed Tuesday’s trading session at $1.80after an uptick the decline following its announcement of the latest update on Tonmya.
The biopharma recently released an update of Tonmya, the treatment that it has been developing for posttraumatic stress disorder (PTSD). Tonix is currently running the Phase 3 clinical trial for the pipeline PTSD drug. The U.S Food and Drug Administration (FDA) granted Tonmya a Breakthrough Therapy Destination (BTD) as a pipeline PTSD treatment in December 2016. However, the BTD was withdrawn because Tonmya’s interim data collected from its HONOR study was not enough to support the BTD continuation.
“The rescission of Breakthrough Therapy designation of Tonmya for PTSD does not alter our NDA plan and will have minimum impact on our future interactions with the FDA,” stated Tonix CEO Seth Lederman.
The CEO also noted that the company is on track to kick off its Phase 3 RECOVERY trial which will focus on both military and civilian PTSD patients. He also expressed gratitude for the FDA’s support on Tonmya’s development process. The company is still determined to speed up Tonmya’s development so that it will be available to PTSD patients as soon as possible.
Tonmya’s phase 2 and phase 3 studies have so far shown consistency
Dr. Lederman also pointed out that the treatment has demonstrated a lot of potential in its Phase 2 and Phase 3 clinical trials that have already taken place. The Phase 3 HONOR study’s retrospective analysis demonstrated treatment activity in study subjects during the nine years that the study has been ongoing. The CEO revealed that the clinical trial results have also shown consistency between Phase 2 and Phase 3 trial results.
Despite his positive remarks, Dr. Lederman emphasized the importance of an early diagnosis so that treatment can be delivered as early as possible. Patients that have had the condition for more than nine years are likely to miss out on the benefits that the treatment has to offer. Tonix Chief Medical Officer Dr. Gregory Sullivan stated that currently available treatments for military-related PTSD do not deliver consistent therapeutic benefits.