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 in 15 years.”
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.
1Moldofsky H, et al. Psychosom Med.
1975;37:341-51
2Moldofsky H, Scarisbrick P. Psychosom Med.
1976;38:35-44
3Fitzcharles MA, et al. Lancet.
2021;397:2098-110
4Clauw DJ. Ann Rheum Dis. Published Online
First: 2024
5Kaplan CM, et al. Nat Rev Neurol. 2024;20,
347–363
About Fibromyalgia
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 of Long
COVID
About TNX-102 SL
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
2024.
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.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; risks related to the
timing and progress of clinical development of our product
candidates; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and substantial
competition. As with any pharmaceutical under development, there
are significant risks in the development, regulatory approval and
commercialization of new products. Tonix does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, and periodic reports filed with the SEC on or after the date
thereof. All of Tonix's forward-looking statements are expressly
qualified by all such risk factors and other cautionary statements.
The information set forth herein speaks only as of the date
thereof.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Katie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
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