Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has given an oral presentation of encouraging results from the Phase 3 clinical study, RELIEF evaluating its TNX-102 SL for fibromyalgia treatment.
Tonix announces positive results of Phase 3 RELIEF trial of TNX-102 SL
The presentation by Tonix Chief Medical Officer Gregory Sullivan was 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.” Results indicated that TNX-102 SL met the pre-specified primary objective in the Phase 3 RELIEF study of daily pain reduction relative to placebo in fibromyalgia patients.
Also, when the primary goal was reviewed as a pain responder analysis, the number of subjects that of responded to TNX-102 SL relative to placebo. Interestingly 5.6mg TNX-102 SL demonstrated activity in major secondary endpoints showing improvements in sleep quality, fatigue mitigation, and functional recovery specific to fibromyalgia.
TNX-102 SL and placebo had identical early discontinuation rates (16.5 percent and17.7 percent, respectively). Furthermore, TNX-102 SL was well tolerated, with oral hypoaesthesia being the most prevalent adverse event from active treatment. Oral hypoesthesia is a sensory injection site reaction that is normally temporary, which was not assessed as severe in the study, but only resulted in one discontinuation.
Results show TNX-102 SL has a wide syndromal impact on fibromyalgia
CEO and President of Tonix Seth Lederman said, “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. 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.”
