Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Presented Data and Analyses
Treatment Effects on Fibromyalgia, the Prototypic Nociplastic Pain Syndrome,
at the IASP 2024 World Congress on Pain
Bedtime TNX-102 SL (sublingual cyclobenzaprine HCl)
treatment in the Phase 3 RESILIENT study
resulted in statistically significant improvement in the primary endpoint of fibromyalgia nociplastic
and in all six key secondary endpoints, including sleep quality
Post hoc analyses highlight the strong correlations
between improvements in nociplastic pain and sleep quality
Nociplastic pain originates from altered pain perception
in the brain and is the type of pain that manifests in fibromyalgia
and other chronic overlapping pain conditions (COPCs)
FDA granted TNX-102 SL Fast Track designation for
the management of fibromyalgia;
NDA submission on track for second half 2024
CHATHAM, N.J., August 12, 2024 (GLOBE NEWSWIRE)
- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed
products and a pipeline of development candidates, presented data in a poster presentation at the International Association for the Study
of Pain (IASP) 2024 World Congress on Pain, held August 5-9, 2024 in Amsterdam, the Netherlands. A copy of the Company's poster
presentation titled, "Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl):
Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromal Improvement", is available under the Scientific Presentations
tab of the Tonix website at www.tonixpharma.com.
TNX-102 SL met the pre-specified primary endpoint
in the Phase 3 RESILIENT study, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia.
TNX-102 SL also demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary
endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia
symptoms and function. A new post hoc analysis showed correlations between improvements in pain and sleep quality at Week 14, supporting
the concept that targeting sleep quality has the potential to achieve syndromal improvement in fibromyalgia. TNX-102 SL was well tolerated
with an adverse event profile comparable to prior studies and no new safety signals observed.
"Approximately 50 years ago, the central
role of nonrestorative sleep in the pathogenesis and persistence of fibromyalgia was recognized by Dr. Harvey Moldofsky1,2",
said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "TNX-102 SL was designed as a bedtime treatment to target
non-restorative sleep and improve sleep quality. The statistically significant results of TNX-102 SL in two positive Phase 3 studies provide
evidence of the activity and tolerability of TNX-102 SL in fibromyalgia and also support the critical role of sleep quality in the pathogenesis,
persistence and exacerbations of fibromyalgia originally proposed by Dr. Moldofsky."
Greg Sullivan, M.D., Chief Medical Officer,
added, "Today, fibromyalgia is recognized as the prototypic nociplastic syndrome'. Understanding nociplastic syndromes
is crucial for developing effective treatment strategies for chronic overlapping pain conditions (COPCs)3,4,5. Traditional
analgesics like NSAIDs or opioids often prove ineffective if not deleterious in these conditions. In contrast, TNX-102 SL provided broad-spectrum
symptom relief in the RESILIENT study. We believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients
TNX-102 SL was recently granted Fast Track designation
by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Tonix remains on track to submit an NDA to the FDA
in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.
1 Moldofsky H, et al.
Psychosom Med. 1975;37:341-51
2 Moldofsky H, Scarisbrick
P. Psychosom Med. 1976;38:35-44
3 Fitzcharles MA, et al.
Lancet. 2021;397:2098-110
4 Clauw DJ. Ann Rheum
Dis. Published Online First: 2024
5 Kaplan CM, et al. Nat Rev
Neurol. 2024;20, 347-363
Fibromyalgia is a chronic pain disorder that is understood
to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults
in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue,
and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches,
and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life,
and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the
recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context
TNX-102 SL is a centrally acting, non-opioid, non-addictive,
bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management
of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in
RESILIENT, the second pivotal Phase 3 clinical trial of TNX-102 SL for the management of fibromyalgia. In the study, TNX-102 SL met its
pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically
significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing
fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of TNX-102
SL in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo
(p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was
tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and
rarely led to study discontinuation (one participant in each study). TNX-102 SL was recently granted Fast Track Designation by the FDA
for the management of fibromyalgia and remains on track to submit an NDA to the U.S. Food and Drug Administration in the second half of
About Nociplastic Pain
Nociplastic pain is the third category of pain distinct
from nociceptive pain and neuropathic pain. Nociplastic pain is characterized by pain arising from altered nociception despite no evidence
of actual or threatened tissue damage causing activation of peripheral nociceptors or somatosensory system disease or lesion. Its underlying
pathophysiology involves altered pain processing by the central nervous system (CNS). Nociplastic syndromes, officially recognized by
the International Association for the Study of Pain (IASP) in 2017, also include several other chronic overlapping pain conditions: myalgic
encephalomyelitis/chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, forms of chronic back pain and chronic
headache. The pathophysiology of nociplastic pain involves central sensitization (CS), where neurons of the CNS become hyperexcitable,
amplifying pain signals. CS can be triggered by peripheral pain stimuli, emotional stress, or other factors, leading to persistent pain
despite no peripheral nociceptive input.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company
focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's
development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application
(NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies
have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of
fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix's CNS portfolio includes TNX-1300 (cocaine
esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development
portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment
of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines,
our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra
(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix's product development
candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks
of Tonix Medicines. All other marks are property of their respective owners.