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Tonix Pharmaceuticals Announces Two Poster Presentations of TNX-102 SL (Sublingual Cyclobenzaprine HCl) at the ASCP Annual Meeting
In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function Phase 2,
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function Phase 2, investigator-initiated OASIS trial is designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision First patient in OASIS expected to enroll in second quarter 2024 CHATHAM, N.J., May 30, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 in Miami Beach, Fla. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. In the poster presentation titled, “Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on Pain, Sleep, Fatigue, and Cognition in Fibromyalgia-Type Long COVID: Results of a Double-Blind Randomized Proof-of-Concept Phase 2 Study,” TNX-102 SL showed a robust effect size of 0.5 in improving fatigue and showed consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at Week 14. Prior to the trial, Tonix had pre-specified that any effect size greater than 0.2 would be considered of interest for further study and, even given a substantial placebo response in pain magnitude measurements, key endpoints such as sleep quality diary (ES = 0.23), PROMIS Sleep Disturbance (ES = 0.32), PROMIS Fatigue (ES = 0.50), PROMIS Cognitive Function (ES = 0.21), the Insomnia Severity Index (ES = 0.24) and the Sheehan Disability Scale (ES = 0.26) all matched the criterion for further evaluation. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. “These results further support the growing evidence that for most Long COVID patients, symptoms are at least partly driven by central nervous system mechanisms rather than persistent exposure to the SARS-CoV-2 virus,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “While To...