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 U.S. Food
and Drug Administration (FDA) has cleared the Investigational New
Drug (IND) application for the Phase 2 investigator-initiated OASIS
trial to evaluate TNX-102 SL1 in reducing the severity of acute
stress reaction (ASR) and the frequency of acute stress disorder
(ASD) and posttraumatic stress disorder (PTSD). The trial is
sponsored by The University of North Carolina (UNC) Institute for
Trauma Recovery and supported by a $3 million grant from the U.S.
Department of Defense (DoD).
“No medication is currently available at or near
the point-of-care to treat patients suffering from traumatic events
and support long-term health,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix. “There is an unmet need for treating
ASR after traumatic events such as civilian motor vehicle
collisions or warfighter experiences in forward bases or in
theater. Previous trials of TNX-102 SL in PTSD suggested activity
on sleep and stress related symptoms in the first several weeks of
treatment.2,3 The study is motivated by the observation that the
symptoms of ASR and PTSD are similar and by the hypothesis that
TNX-102 SL’s effect on sleep quality may reduce ASR symptoms.”
The Optimizing Acute Stress Reaction
Interventions with TNX-102 SL (OASIS) trial will examine the safety
and efficacy of TNX-102 SL to reduce adverse posttraumatic
neuropsychiatric sequelae among patients presenting to the
emergency department (ED) after a motor vehicle collision. The
trial will enroll approximately 180 trauma survivors at ED study
sites around the U.S. Participants will be randomized in the ED to
receive a two-week course of either TNX-102 SL 5.6 mg or
placebo.
The OASIS trial will build upon a foundation of
knowledge and infrastructure developed through the UNC-led, $40
million AURORA initiative. AURORA is a major national research
initiative to improve the understanding, prevention, and recovery
of individuals who experience a traumatic event. AURORA is
supported by funding from the National Institutes of Health (NIH),
leading brain health nonprofit One Mind, private foundations, and
partnerships with leading tech companies such as Mindstrong Health
and Verily Life Sciences, the healthcare arm of Alphabet, the
parent company of Google.
“This innovative clinical trial and partnership
will help address the need for safe and effective therapies to
treat acute trauma,” said Samuel McLean, M.D., Professor of
Psychiatry and Emergency Medicine at the UNC School of Medicine at
UNC, School of Medicine, and lead principal investigator of the
proposed study. “ASR and posttraumatic stress symptoms are common
among civilian motor vehicle collision survivors. The AURORA
initiative, which has collected thousands of data points from motor
vehicle collisions, has allowed us to better investigate the
correlation between motor vehicle collisions and the emergence of
acute stress disorder or PTSD symptoms. In OASIS, we will test a
pharmacological intervention in the immediate aftermath of trauma
that has potential for fast relief of stress symptoms, improvement
in coping and functioning, and preclusion of escalation to more
severe conditions, ASD in the short term and PTSD thereafter.”
Acute and chronic stress disorders can affect
both civilian and military populations. According to the National
Center for PTSD, in the U.S. about 60% of men and 50% of women
experience at least one trauma in their lives.4 In the U.S.
alone, one-third of emergency department visits (40-50 million
patients per year) involve evaluation after trauma exposures, and
in a 2014 study involving 3,157 US veterans, 87% reported exposure
to at least one potentially traumatic event during their
service.5 Moreover, as many as 500,000 U.S. troops who served
in wars between 2001 and 2015 were diagnosed with PTSD.6
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 for
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 cyclobenzaprine 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 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 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.
- TNX-102 SL (cyclobenzaprine HCl
sublingual tablets) has not been approved for any indication;
(Tonmya™ is conditionally approved by FDA for the management of
fibromyalgia)
- Sullivan GM, et al. Randomized
clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL)
in military-related PTSD and the role of sleep quality in treatment
response. Psychiatry Res. 2021 Jul;301:113974.
- Parmenter ME, et al. A phase 3,
randomized, placebo-controlled, trial to evaluate the efficacy and
safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in
military-related posttraumatic stress disorder. Psychiatry Res.
2024 (In Press).
https://doi.org/10.1016/j.psychres.2024.115764
- Goldstein RB, et al. Soc Psychiatry
Psychiatr Epidemiol. 2016. 51(8):1137-48
- Wisco BE, et al. J Clin Psychiatry.
2014. 75(12):1338-46
- Thompson M. Time.
2015;185(12):40-3
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.com(919)
360-3039
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