Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that the first 50% of participants have been randomized
in the Phase 3 RESILIENT study of TNX-102 SL (cyclobenzaprine HCl
sublingual tablets) 5.6 mg for the management of fibromyalgia. An
interim analysis by an Independent Data Monitoring Committee (IDMC)
of the first 50% of randomized participants for a potential sample
size adjustment or early stop for futility is expected in the
second quarter of 2023.
TNX-102 SL is in mid-Phase 3 development for the
management of fibromyalgia, a chronic pain disorder that afflicts
between 6 and 12 million adults in the U.S., of which 90 percent
are women. Despite dissatisfaction with currently marketed
products, no new treatment for fibromyalgia has been approved by
the FDA since 2009.
In December 2020, Tonix reported positive
results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg
for the management of fibromyalgia (primary endpoint, p=0.010).
Several secondary measures in RELIEF highlighted the broad effects
of TNX-102 SL across several cardinal symptoms of fibromyalgia
beyond pain. In March 2022, Tonix reported results of a subsequent
Phase 3 study (RALLY) in which TNX-102 SL did not achieve
statistical significance on the primary endpoint (p=0.115).
Relative to the previous positive Phase 3 study (RELIEF), RALLY had
an unexpected increase in study participant adverse event-related
discontinuations in both the drug and placebo groups. TNX-102 SL
was generally well tolerated in both studies with an adverse event
profile comparable to prior studies, and no new safety signals
observed.
“We are pleased to have reached this important
milestone in our ongoing development of TNX-102 SL for
fibromyalgia. RESILIENT is a potentially pivotal and confirmatory
Phase 3 study, and we look forward to the IDMC's assessment of
interim results in the second quarter of 2023,” said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals.
“Fibromyalgia is a complex syndrome in which many patients remain
unsatisfied by existing treatment options. Approximately one-fourth
of people with fibromyalgia resort to prescription opioids for
analgesia1. TNX-102 SL is a centrally acting analgesic that has the
potential to be a new non-addictive, non-opioid bedtime medication
for the management of fibromyalgia with broad spectrum symptom
coverage.”
1Sarmento, CVM, et al. (2019) “Opioid prescription patterns
among patients with fibromyalgia.” J Opioid Manag. 15(6):469-477.
doi: 10.5055/jom.2019.0537. PMID: 31850508
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 is
expected to enroll approximately 470 participants 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 (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14
(using the weekly averages of the daily numerical rating scale
scores), analyzed by mixed model repeated measures with multiple
imputation. An interim analysis by an Independent Data Monitoring
Committee will be conducted on the primary endpoint based on the
first 50% of enrolled participants for a potential sample size
adjustment or early stop for futility.
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, PTSD, 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 clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022 and
expects interim data in the third quarter of 2023. 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 first quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
expected to enter the clinic with a Phase 2 study in the first
quarter of 2023. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily formulation of tianeptine
being developed as a potential treatment for major depressive
disorder (MDD) with a Phase 2 study expected to be initiated in the
first quarter of 2023. Tonix’s rare disease 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 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 and xenograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the first half of 2023. Tonix’s
infectious disease pipeline consists of a vaccine in development to
prevent smallpox and monkeypox, next-generation vaccines to prevent
COVID-19, and a platform to make fully human monoclonal antibodies
to treat COVID-19. TNX-801, Tonix’s vaccine in development to
prevent smallpox and monkeypox, also serves as the live virus
vaccine platform or recombinant pox vaccine (RPV) platform for
other infectious diseases. A Phase 1 study of TNX-801 is expected
to be initiated in Kenya in the second half of 2023. Tonix’s lead
vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines
based on Tonix’s recombinant pox live virus vector vaccine
platform.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
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; delays and uncertainties caused
by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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