Benzinga | Nov 9, 2021 11:08AM EST

Tonix Pharma Highlights Presentation of Phase 3 RELIEF Study Of TNX-102 SL For Mgmt. Of Fibromyalgia At American College Of Rheumatology Convergence

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an oral presentation of positive results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia. A copy of the presentation is available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

The presentation, titled, "TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial" by Dr. Gregory Sullivan, Chief Medical Officer of Tonix, reports that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia. Also, when the primary endpoint was analyzed as a ?30% pain responder analysis, there was a higher rate of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints demonstrating improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery.

Early discontinuation rates were similar for TNX-102 SL and placebo (16.5% and17.7%, respectively). In addition, TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral hypoaesthesia, a sensory administration site reaction that is typically transient, was never rated as severe, and only lead to one discontinuation.

"Results of the Phase 3 RELIEF trial demonstrated that TNX-102 SL had broad syndromal effects across core fibromyalgia symptoms of widespread pain, fatigue, memory and sleep disturbance," said Seth Lederman, M.D., President and Chief Executive Officer. "The positive Phase 3 RELIEF study achieved statistical significance on the primary endpoint in December, 2020. We had started a second Phase 3 study, RALLY in September 2020. Based on disappointing efficacy results at the interim analysis of RALLY in July 2021, we stopped enrolling new participants. Topline results from RALLY are expected before year end. The Company will determine the next steps in this program based on analysis of the RALLY data, which will include pharmacogenomic analyses of RALLY and RELIEF."