Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) shares were up sharply on Thursday after the company announced an update from the U.S. Food and Drug Administration (FDA).
Essentially, the minutes from the FDA Breakthrough Therapy Type B Clinical Guidance meeting were released. These minutes were consistent with the preliminary guidance the company received at the meeting and confirm the FDA’s acceptance of the new Phase 3 “Recovery” study design.
As previously communicated, Tonix plans to start the Recovery trial for the treatment of post-traumatic stress disorder (PTSD) in the first quarter of 2019. The new trial will incorporate several new design features, including restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening, instead of 2001 or later as in the Phase 3 Honor study.
The Recovery study also will include participants who have experienced civilian traumas in addition to those with military-related traumas. The primary endpoint, mean change from baseline in the severity of PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), is the same as that used in the Phase 3 Honor study and the Phase 2 AtEase study, but the CAPS-5 primary endpoint will be assessed at Week 4 instead of at Week 12.
Based on the Week 4 primary endpoint, roughly 250 patients will be enrolled in the Recovery trial, compared to 550 patients targeted for the previous Phase 3 Honor study, which utilized a primary endpoint assessed at week 12.
Seth Lederman, M.D., president and CEO of Tonix commented:
The minutes from our Breakthrough Therapy Clinical Guidance meeting with the FDA are consistent with our previous assessment. We are moving forward expeditiously to initiate the RECOVERY study in the first quarter of 2019 and expect to have topline data in the first half of 2020.
Shares of Tonix were last seen up 95% at $7.43, in a 52-week range of $0.36 to $9.00. The consensus analyst price target is $1.81.