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Tonix Pharmaceuticals Initiates Enrollment in Second Potentially Pivotal Phase 3 Study, the RALLY Study, of TNX-102 SL for the Management of Fibromyalgia
Interim Analysis Results from Ongoing Phase 3 RELIEF Study Expected in September; Topline Results Expected in Fourth Quarter 2020 Positive Outcomes in Both
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Interim Analysis Results from Ongoing Phase 3 RELIEF Study Expected in September; Topline Results Expected in Fourth Quarter 2020\n Positive Outcomes in Both Trials Would Support Submission of NDA in Second Half 2022 NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 3 RALLY study (TNX-CY-F306) of TNX-102 SL 5.6 mg for the management of fibromyalgia. RALLY is the Company’s second of two potentially pivotal Phase 3 studies of TNX-102 SL, a proprietary sublingual tablet formulation of cyclobenzaprine HCl taken daily at bedtime for the management of fibromyalgia. “This is an important milestone for Tonix and potentially for the nation’s roughly 8 million adult fibromyalgia sufferers,” said Seth Lederman, M.D., President and Chief Executive Officer. “Our team is dedicated to advancing TNX-102 SL, which is being developed as a novel, non-opioid, non-addictive, centrally-acting analgesic.” “Not only has the number of fibromyalgia sufferers remained high, the stigma associated with a fibromyalgia diagnosis has decreased due to greater knowledge of the neurobiological underpinnings,” Dr. Lederman continued. “And many people with fibromyalgia are still dissatisfied with available treatments. Tolerability can be a problem for some with the approved medications. Addiction can be a problem with off-label use of opiates. TNX-102 SL has the potential to provide relief from the pain, fatigue, sleep disturbance and dysfunction from fibromyalgia with good tolerability and without addictive potential.” Both of the current Phase 3 trials are studying TNX-102 SL at a dose of 5.6 mg which is twice the 2.8 mg dose used in the Company’s prior Phase 2 and 3 studies in fibromyalgia. Tolerability of the higher dose was documented in an earlier Phase 3 trial of TNX-102 SL in posttraumatic stress disorder (PTSD). Both of the current Phase 3 fibromyalgia studies are being conducted using essentially the same protocol. An interim analysis of the first of the current fibromyalgia trials, RELIEF, is expected by the end of September, with topline results expected by year end. If the RALLY study maintains current enrollment timelines and objectives, it is expected to report topline d...