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Tonix Pharmaceuticals Announces Enrollment of Phase 3 RELIEF Trial of TNX-102 SL for Management of Fibromyalgia is Ahead of Schedule
Topline Results Expected Fourth Quarter 2020 Due to Faster than Previously Projected Enrollment Completion of Trial Enrollment Anticipated Early Third Quarter
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Topline Results Expected Fourth Quarter 2020 Due to Faster than Previously Projected Enrollment\n Completion of Trial Enrollment Anticipated Early Third Quarter 2020 Interim Results from the First 50 Percent of Participants Continue to be Expected in September 2020 NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that due to faster-than-expected enrollment, the Company anticipates topline Phase 3 RELIEF results in the fourth quarter of 2020, rather than the first quarter of 2021 as previously guided. RELIEF is a potential pivotal study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia. An optional interim analysis of the first 50 percent of randomized participants that are evaluable for efficacy will be conducted, with results expected in September 2020. “We are pleased to announce that we will achieve our recruitment goal ahead of schedule. We have worked diligently to ensure the safe and timely recruitment of the RELIEF trial before and during the COVID-19 pandemic,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Fibromyalgia affects millions of adults globally and we believe that TNX-102 SL has the potential to offer a new, non-addictive treatment option for patients seeking relief from this disorder.” About the Phase 3 RELIEF Study The RELIEF study is a double-blind, randomized, placebo-controlled adaptive design trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg in fibromyalgia. The trial is expected to enroll approximately 470 participants across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. Additional details about the RELIEF...