Business
Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 RECOVERY Study of Tonmya® (TNX-102 SL) in PTSD
RECOVERY Study has Stopped Enrollment Due to Inadequate Separation from Placebo at Week-12 Based on Interim Analysis Results of the First 50% of Enrolled
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"RECOVERY Study has Stopped Enrollment Due to Inadequate Separation from Placebo at Week-12 Based on Interim Analysis Results of the First 50% of Enrolled Participants\n Company Plans to Unblind and Report Top Line Results in the Second Quarter After Currently Enrolled Study Participants Have Completed Company is Currently Enrolling a Phase 3 Study of TNX-102 SL in Fibromyalgia Syndrome and Expects Interim Results in the Third Quarter NEW YORK, Feb. 05, 2020 (GLOBE NEWSWIRE) -- 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...