Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or
the Company), a biopharmaceutical company with marketed products
and a pipeline of development candidates, today announced that it
has engaged Rho, Inc. (Rho), a global contract research
organization (CRO), to support Tonix’s preparation and planned
submission of its New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for the approval of Tonmya™
(cyclobenzaprine HCl sublingual tablets) for the management of
fibromyalgia.
“We are excited by our most recent positive
Phase 3 study results of Tonmya and look forward to Rho’s support
in preparing our NDA,” said Seth Lederman, M.D., President and
Chief Executive Officer of Tonix Pharmaceuticals. “We intend to
meet with the FDA in the first half of this year and to submit our
NDA in the second half of the year. We believe we have completed
all development work required for the NDA, including CMC
requirements and the completion of two positive Phase 3
studies.”
Tonmya is a patented sublingual tablet
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, a second positive Phase 3 clinical trial of
Tonmya for the management of fibromyalgia. In the study, Tonmya 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. RELIEF, the first positive
Phase 3 trial of Tonmya 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.
“We are delighted in our continued support of
Tonix and their Tonmya program,” said Tara Gladwell, President and
COO at Rho. “We are hopeful that this work may result in a new
treatment for the millions of Americans that suffer from this
debilitating, chronic disorder.”
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 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 Tonmya™ (also known as TNX-102
SL)
Tonmya is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride which is designed for
daily administration at bedtime with a proposed mechanism of
improving sleep quality in fibromyalgia. Tonmya 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, Tonmya is in development as a daily bedtime treatment
for fibromyalgia. TNX-102 SL is also in development
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 Tonmya composition. These patents
are expected to provide Tonmya, 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.
About Rho
Rho is a global, privately held contract
research organization (CRO) headquartered in Research Triangle
Park, a biotech hub in North Carolina, US. Rho provides a full
range of drug development services, from program strategy through
to clinical trials and marketing applications. Since 1984, Rho has
been a trusted partner to some of the most innovative
pharmaceutical, biotechnology and medical device companies as well
as academic and government organizations. Dedicated to service
excellence and cross-functional collaboration, Rho’s therapeutic
expertise, employee focus and commitment to strong site
relationships change what it means to work with a CRO –
accelerating time to market, maximizing ROI, and delivering
consistent, smarter and more efficient programs. Experience Rho by
following the company on LinkedIn.
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 Tonmya, 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 Tonmya for the management of fibromyalgia in the second
half of 2024. TNX-102 SL is being developed to reduce the severity
of acute stress reaction and the frequency of acute stress disorder
and posttraumatic stress disorder. This trial is being sponsored by
the University of North Carolina and received funding support from
the U.S. Department of Defense. 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 and
received funding from the National Institute on Drug Abuse (NIDA).
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 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
Tonix Pharmaceuticals (NASDAQ:TNXP)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024