Tonix Pharma (TNXP) Phase 3 RECOVERY Study of Tonmya in PTSD Halted Due to Futility

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that the Company has decided to stop enrollment in the Phase 3 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 3 fibromyalgia study of TNX-102 SL 5.6 mg that is currently enrolling and from which interim results are expected in the third quarter.

“We are disappointed for patients suffering from PTSD that the interim analysis did not detect a signal that would warrant continued enrollment in this Phase 3 study.” commented Seth Lederman, M.D., President and Chief Executive Officer. “These results underscore the difficulty in treating PTSD.”

* TNX-102 SL is an investigational new drug and has not been approved for any indication.# Tonmya is the FDA conditionally accepted proprietary name for TNX-102 SL for the treatment of PTSD

About the Phase 3 RECOVERY Study

The RECOVERY study is a double-blind, randomized, placebo-controlled, adaptive design study evaluating the efficacy and safety of Tonmya 5.6 mg over 12 weeks of treatment for civilian and military-related PTSD. The study is designed to enroll approximately 250 participants across approximately 30 clinical sites in the U.S. An interim analysis was conducted by an unblinded IDMC for potential sample size re-estimation after half the target population was enrolled and evaluable. Enrollment is 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.

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