Tonix Pharmaceuticals (NASDAQ:TNXP) rose sharply Thursday after the company disclosed that it has received minutes from Breakthrough Therapy Guidance meeting with the U.S. Food and Drug Administration.
The New York-based Tonix says the minutes are consistent with the preliminary guidance the Company received at the meeting and confirm FDA’s acceptance of the new Phase 3 "RECOVERY" study design.
TNXP plans to start the RECOVERY trial for the treatment of posttraumatic 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 will also include participants who have experienced civilian traumas in addition to those with military-related traumas.
The company says, 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.
According to CEO Seth Lederman, "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."
Tonix shares hiked $5.46, or 143.7%, to $9.26
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