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 an oral presentation at the 2024 Military Health
System Research Symposium (MHSRS), held August 26-29, 2024, in
Kissimmee, Fla. A copy of the Company’s presentation, titled
“Assuaging Agony: Novel Pain Therapeutics”, is available under the
Scientific Presentations tab of the Tonix website at
www.tonixpharma.com.
In the Phase 3 RESILIENT study, TNX-102 SL met
the pre-specified primary endpoint of significantly reducing daily
pain compared to placebo (p-value=0.00005) in participants with
fibromyalgia. TNX-102 SL 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 post hoc analysis
showed strong 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.
“Traditional analgesics like NSAIDs or opioids
often prove ineffective, if not deleterious, as strategies for
treating fibromyalgia,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “In contrast, TNX-102 SL provided
broad-spectrum symptom relief in the Phase 3 RESILIENT study and
was designed as a bedtime treatment to target non-restorative sleep
and improve sleep quality. With the statistically significant
results of two positive Phase 3 studies of TNX-102 SL in
fibromyalgia we believe TNX-102 SL has the potential to be the
first new treatment option for fibromyalgia patients in 15
years.”
Dr. Lederman continued, “Fibromyalgia is the
prototypic nociplastic syndrome and chronic overlapping pain
condition (COPC)3,4,5. Our results in fibromyalgia suggest
potential for TNX-102 SL in treating other COPCs like
post-concussive syndrome6, in which sleep disturbances correlate
with persistence and severity. In addition, we expect to begin
enrolling this quarter in a trial of TNX-102 SL for acute stress
disorder/acute stress reaction in the immediate aftermath of motor
vehicle collision in the U.S. Department of Defense (DoD)-funded
Optimizing Acute Stress Reaction Interventions (OASIS) trial
conducted by the University of North Carolina under an
investigator-initiated investigational new drug (IND)
application.
Tonix remains on track to submit a new drug
application (NDA) to the FDA in the second half of 2024 for TNX-102
SL for the management of fibromyalgia. A decision on approval is
expected in 2025.
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
6Kureshi S et al. Healthcare (Basel) 2024 12(3):
289.
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
FDA 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 recently announced the U.S. DoD, Defense Threat
Reduction Agency (DTRA) awarded it a contract for up to $34 million
over five years to develop TNX-4200 small molecule broad-spectrum
antiviral agents targeting CD45 for the prevention or treatment of
infections to improve the medical readiness of military personnel
in biological threat environments. Tonix owns and operates a
state-of-the art infectious disease research facility in Frederick,
MD. The company also owns a Good Manufacutring Practice
(GMP)-capable advanced manufacturing facility in Dartmouth, MA,
which was purpose-built to manufacture TNX-801, a potential mpox
vaccine, and the GMP suites are ready to be reactivated in case of
a national emergency. Tonix’s development portfolio is focused on
CNS disorders. Tonix’s priority is to submit an 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, which is enrolling in a
potential pivotal Phase 2 trial. 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
Lisa
DeScenzaLaVoieHealthScienceldescenza@lavoiehealthscience.com(617)
351-0243
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