Tonix Pharmaceuticals Holding Corp (TNXP)

[mick]

$TNXP i missed dis.
re;
Tonix Pharmaceuticals Initiates Enrollment in Second Potentially Pivotal Phase 3 Study, the RALLY Study



Interim Analysis Results from Ongoing Phase 3 RELIEF Study Expected in September; Topline Results Expected in Fourth Quarter 2020

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.

https://www.globenewswire.com/news-release/2020/09/03/2088540/0/en/Tonix-Pharmaceuticals-Initiates-Enrollment-in-Second-Potentially-Pivotal-Phase-3-Study-the-RALLY-Study-of-TNX-102-SL-for-the-Management-of-Fibromyalgia.html



Tonix Pharmaceuticals Holding Corp (TNXP)