Tonix Pharmaceuticals Announces Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia

New 5.6 mg Dose Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01)

TNX-102 SL Generally Well Tolerated with Adverse Event Profile Comparable to Prior Studies; No New Safety Signals Observed

Approximately 90% of Those Affected by Fibromyalgia are Women; 95% of Participants in the RELIEF Study were Women

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CHATHAM, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia in the Phase 3 RELIEF study (Table 1). TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, taken once daily at bedtime, being developed for the management of fibromyalgia. RELIEF was a 14-week randomized, double-blind, placebo-controlled trial of TNX-102 SL 5.6 mg, in which 503 participants with fibromyalgia were randomized in a 1:1 ratio across 39 U.S. sites. All participants received one tablet of TNX-102 SL (2.8 mg) or placebo for the first two weeks, which was increased to two tablets of TNX-102 SL (5.6 mg) or placebo for the remaining 12 weeks.

“Tonix is dedicated to improving the lives of the millions suffering from fibromyalgia, approximately 90% of whom are female, and the results of the RELIEF trial bring new hope to this community,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL at 5.6 mg showed statistically significant and clinically meaningful improvement on the primary endpoint of reducing daily pain, as well as showed activity in key secondary endpoints of improving sleep and reducing fatigue. One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability. We are pleased with the consistent effects of TNX-102 SL 5.6 mg on the primary endpoint of daily pain as well as the tolerability of this dose in the RELIEF study. We are also pleased at the activity shown on all of the fibromyalgia specific, pre-specified secondary endpoints. We look forward to the results of the currently enrolling, second potential pivotal Phase 3 study, RALLY, for which we expect to report topline data in the second half of 2021. Based on the long term safety exposure data we have already collected, the mature stage of our Good Manufacturing Practice (GMP) manufacturing processes and the established product stability at 36 months, we believe that upon achieving positive results from the currently enrolling RALLY study, we may potentially be in a position to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022. Additionally, we believe that our commercial manufacturing is on track to supply the U.S. market in 2022.”

Table 1. Results of Primary and Secondary Endpoints