After Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced that it is beginning to enroll patients in its late-stage study of Tonmya for the treatment of post-traumatic stress disorder (PTSD), its shares made a solid gain on Monday.
This study is designed to enroll roughly 250 participants across 30 clinical sites in the United States. Enrollment will be restricted to individuals with PTSD who experienced an index trauma within nine years of screening.
The primary efficacy endpoint will be the mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between those treated with Tonmya and those receiving placebo.
The CAPS-5 is a standardized structured clinical interview and serves as the standard in research for measuring the symptom severity of PTSD. Earlier versions of the CAPS were used to support the approval of the two currently marketed PTSD treatments.
Some quick background: PTSD affects about 12 million Americans and is a chronic and severely debilitating condition.
Seth Lederman, M.D., Tonix’s president and CEO, commented:
Tonix is committed to improving the lives of the millions who suffer from PTSD, especially military-related PTSD, and enrolling the first participant in the Recovery study is an important step towards achieving this goal. We believe the innovative design features of the Recovery study, which are based on careful analyses of data from our prior PTSD trials, in addition to FDA feedback, may increase the probability of success of the Recovery study. We look forward to progressing enrollment and to anticipated topline results in the first half of next year.
Shares of Tonix were last seen up about 18% at $3.31, in a 52-week range of $0.36 to $9.60. The consensus price target is $14.00.