Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced the completion
of the clinical phase of the Phase 3 registration-quality,
double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2
(cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management
of fibromyalgia. A total of 457 patients were enrolled in this
multi-site study in the U.S. Topline results are expected in late
December 2023. If successful, it is expected to be the final,
well-controlled efficacy trial required for submission of a New
Drug Application (NDA) for approval by the U.S. Food and Drug
Administration (FDA).
“There are an estimated 6-12 million individuals
in the U.S. suffering from this debilitating condition, most of
whom are women,” said Seth Lederman, M.D., Chief Executive Officer
of Tonix Pharmaceuticals. “TNX-102 SL is a centrally-acting,
non-opioid analgesic bedtime medication designed to be used on a
chronic basis for the management of fibromyalgia. We believe
TNX-102 SL works by improving sleep quality, which leads to
improvement of other symptoms. In previous studies, TNX-102 SL
showed broad coverage across the symptoms of fibromyalgia,
including chronic widespread pain, fatigue and sleep
disturbance.”
“The preliminary unaudited rate of adverse-event
(AE) related discontinuations in the RESILIENT study was 4.8%,”
said Gregory Sullivan, M.D., Chief Medical Officer of Tonix
Pharmaceuticals. “This compares favorably to the blinded AE-related
discontinuation rates in our two previous Phase 3 trials: 6.0% in
RELIEF which achieved statistical significance on the primary
endpoint (p=0.010), and 10.7% in RALLY which was stopped at the
interim analysis. We later learned that an unexpectedly high rate
of AE-related discontinuations in RALLY contributed to missing the
primary endpoint. The study was conducted during the Delta wave of
the COVID pandemic, which we believe may have contributed to
patient discontinuations. AE-related discontinuations are treated
as negative outcomes in the ‘missing data’ multiple imputation
approach that is part of the analysis of the primary endpoint.”
In December 2020, Tonix reported positive
results from the first Phase 3 RELIEF study of TNX-102 SL 5.6 mg
for the management of fibromyalgia.3 TNX-102 SL met its
pre-specified primary endpoint in the Phase 3 RELIEF trial,
significantly reducing daily pain compared to placebo (p=0.010) in
participants with fibromyalgia. Also, when the primary endpoint was
analyzed as a ≥30% pain responder analysis, there was a higher rate
of responders to TNX-102 SL (47%) than to placebo (35%; p=0.006).
TNX-102 SL at 5.6 mg also showed activity in key secondary
endpoints, demonstrating improvements in sleep quality, mitigation
of fatigue, and fibromyalgia-specific global symptomatic and
functional recovery. TNX-102 SL was generally safe and well
tolerated in patients with fibromyalgia, with overall adverse event
profile comparable to prior fibromyalgia studies. The most common
treatment-emergent adverse events were oral hypoesthesia, oral
paresthesia, and product taste abnormal.
1Clinical Trials.gov I.D. NCT052737492TNX-102 SL is an
investigational new drug and is not approved for any
indication.3Lederman S, et al. Arthritis Care Res. 2023.
75(11):2359-2368.
About the Phase 3 RESILIENT
Study
The RESILIENT study is a double-blind,
randomized, placebo-controlled trial designed to evaluate the
efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) in the management of fibromyalgia. The two-arm trial
randomized 457 participants across 33 sites in the U.S. The first
two weeks of treatment consist of a run-in period in which
participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo.
Thereafter, all participants increase their dose to TNX-102 SL 5.6
mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12
weeks. The primary endpoint is the daily diary pain severity score
change from baseline to Week 14 (using the weekly averages of the
daily numerical rating scale scores) for TNX-102 SL 5.6 mg vs.
placebo, analyzed by mixed model repeated measures with multiple
imputation.
For more information, see ClinicalTrials.gov
Identifier: NCT05273749.
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 an
estimated 6-12 million adults in the U.S., approximately 90% of
whom are women. Symptoms of fibromyalgia include chronic widespread
pain, nonrestorative sleep, fatigue, and morning stiffness. Other
associated symptoms include cognitive dysfunction and mood
disturbances, including anxiety and depression. 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.
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride which provides rapid
transmucosal absorption and reduced production of a long half-life
active metabolite, norcyclobenzaprine, due to bypass of first-pass
hepatic metabolism. As a multifunctional agent with potent binding
and antagonist activities at the 5-HT2A-serotonergic,
α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors,
TNX-102 SL is in development as a daily bedtime treatment for
fibromyalgia, Long COVID (formally known as post-acute sequelae of
COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s
disease. The United States Patent and Trademark Office (USPTO)
issued United States Patent No. 9636408 in May 2017, Patent No.
9956188 in May 2018, Patent No. 10117936 in November 2018, Patent
No. 10,357,465 in July 2019, and Patent No. 10736859 in August
2020. The Protectic™ protective eutectic and Angstro-Technology™
formulation claimed in the patent are important elements of Tonix’s
proprietary TNX-102 SL composition. These patents are expected to
provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity
until 2034/2035.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets Zembrace® SymTouch®
(sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith
Laboratories, LLC from whom the products were acquired on June 30,
2023. Zembrace SymTouch and Tosymra are each indicated for the
treatment of acute migraine with or without aura in adults. Tonix’s
development portfolio is composed of central nervous system (CNS),
rare disease, immunology and infectious disease product candidates.
Tonix’s CNS development portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead development CNS candidate, TNX-102 SL
(cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3
development for the management of fibromyalgia, having completed
enrollment of a potentially confirmatory Phase 3 study in the third
quarter of 2023, with topline data expected in late December 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition. Enrollment in a
Phase 2 proof-of-concept study has been completed, and topline
results were reported in the third quarter of 2023. TNX-1900
(intranasal potentiated oxytocin), is in development as a
preventive treatment for chronic migraine, and enrollment has been
completed in a Phase 2 proof-of-concept study with topline data
expected in early December 2023. TNX-1900 is also being studied in
binge eating disorder, pediatric obesity, bone health in autism,
and social anxiety disorder by academic collaborators under
investigator-initiated INDs. TNX-1300 (cocaine esterase) is a
biologic designed to treat cocaine intoxication and has been
granted Breakthrough Therapy designation by the FDA. A Phase 2
study of TNX-1300 is expected to be initiated in the fourth quarter
of 2023. Tonix’s rare disease development portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug
designation by the FDA. Tonix’s immunology development portfolio
includes 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. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases, including TNX-1800, in development as a vaccine to
protect against COVID-19. The infectious disease development
portfolio also includes TNX-3900 and TNX-4000, which are classes of
broad-spectrum small molecule oral antivirals.
*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. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. 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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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