Enrollment for phase III RECOVERY study of Tonmya in PTSD halted due to futility.- Tonix Pharma

Tonix Pharmaceuticals announced that the Company has decided to stop enrollment in the Phase III RECOVERY study of Tonmya or TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of posttraumatic stress disorder (PTSD) following an unblinded, pre-specified interim analysis by the Independent Data Monitoring Committee (IDMC). Based on interim analysis results of the first 50% of enrolled participants, the IDMC recommended stopping the trial for futility as Tonmya is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall 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.

Preliminary blinded safety data from these participants did not reveal any serious and/or unexpected adverse events and the decision to discontinue enrolling in the study is not related to safety. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data to determine the next steps in this program, with the topline results expected to be reported in the second quarter of 2020. The Company is reallocating resources from the PTSD program to the Phase III fibromyalgia study of TNX-102 SL 5.6 mg that is currently enrolling and from which interim results are expected in the third quarter.