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
presentation of additional safety and tolerability data from
RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) for the management of
fibromyalgia, at Biotech Showcase™ 2024 in San Francisco, January
8-10.
As previously announced, RESILIENT 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 key secondary endpoints related to improving sleep
quality, reducing fatigue, and improving overall fibromyalgia
symptoms and function. Tonix plans to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) in the second
half of 2024 for TNX-102 SL for the management of fibromyalgia.
RELIEF, the first Phase 3 trial of TNX-102 SL
5.6 mg 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 presenting more detailed data from the
RESILIENT study, Seth Lederman, M.D., President and Chief Executive
Officer of Tonix, said, “The results showed that TNX-102 SL
treatment was not associated with increases in systolic or
diastolic blood pressure or body weight, nor were there any
reported sexual side effects. In fact, when systematically
investigated using the Changes in Sexual Functioning Questionnaire
short form (CSFQ-14), women who received study drug had a higher
CSFQ-14 score relative to those who received placebo consistent
with improved sexual function. These are important tolerability
factors for fibromyalgia patients on long-term therapies,
particularly since weight gain is associated with gabapentinoids,
negative sexual side effects are associated with serotonin-reuptake
inhibiting medications, and increased blood pressure is associated
with potent noradrenergic-reuptake inhibiting medications.”
Dr. Lederman added, “We believe that the data
from our two positive Phase 3 studies, with clinically meaningful
separation from placebo on pain, sleep, and fatigue, show that
fibromyalgia can be successfully treated by TNX-102 SL 5.6 mg and
may provide the opportunity for Tonix to launch the first
FDA-approved drug for fibromyalgia in more than a decade.”
“An estimated 6 million to 12 million adults in
the U.S. are living with fibromyalgia, the majority of whom are
women. We believe that these safety and efficacy results will be
important to fibromyalgia patients who struggle not only with pain,
but also multiple other symptoms and potential side effects from
the currently approved pharmacotherapies,” said Gregory Sullivan,
M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Because
fibromyalgia is a chronic condition with treatments intended to be
used on a long-term basis, favorable tolerability and side effect
profiles are integral to managing this debilitating condition and
enhancing the quality of life for those suffering. We are now
another important step closer to bringing a new first-line
treatment to fibromyalgia patients that offers broad symptom relief
with favorable tolerability attributes for chronic use and
adherence.”
About the Phase 3 RESILIENT
StudyThe 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 in the U.S. across 33 sites. 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.
For more information, see ClinicalTrials.gov
Identifier: NCT05273749.
About FibromyalgiaFibromyalgia
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 million to 12 million
adults in the U.S., the majority 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 SLTNX-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 cholinergic receptors, TNX-102
SL is in development as a daily bedtime treatment for fibromyalgia,
fibromyalgia-type 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. In addition, Tonix has
pending but not issued U.S. patent applications directed to the
transmucosal absorption of CBP-HCl, with U.S. market exclusivity
expected until 2033, for treating depressive symptoms in
fibromyalgia, with U.S. market exclusivity expected until 2032, and
for treating pain in fibromyalgia with U.S. market exclusivity
expected until 2041.
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’s development portfolio is focused on
central nervous system disorders. Tonix’s priority is to submit a
New Drug Application (NDA) to the FDA for TNX-102 SL
(cyclobenzaprine HCl sublingual tablet), which has completed two
positive Phase 3 studies for the management of fibromyalgia. Tonix
intends to meet with the FDA in the first half of 2024 and submit
an NDA for the approval of TNX-102 SL for the management of
fibromyalgia in the second half of 2024. TNX-102 SL is also being
developed to treat fibromyalgia-type Long COVID, a chronic
post-acute COVID-19 condition, and topline results from a
proof-of-concept study were reported 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 2024. Tonix’s rare disease development
portfolio includes TNX-2900 (intranasal potentiated oxytocin) for
the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been
granted Orphan Drug designation by the FDA and an investigational
new drug (IND) application has been cleared to support a Phase 2
study in PWS patients. 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. During the fourth quarter of 2023,
TNX-1800 was selected by the U.S. National Institutes of Health
(NIH), National Institute of Allergy and Infectious Diseases
(NIAID) Project NextGen for inclusion in Phase 1 clinical trials.
The infectious disease development portfolio also includes TNX-3900
and TNX-4000, which are classes of broad-spectrum small molecule
oral antivirals. 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 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
StatementsCertain 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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