Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that during a virtual event co-hosted by BIO and Solve
M.E. titled, “Long COVID: What Will it Take to Accelerate
Therapeutic Progress?”, Seth Lederman, M.D., President and Chief
Executive Officer of Tonix Pharmaceuticals, presented emerging
research describing the role of infections in triggering
fibromyalgia or CFS/ME and other fibromyalgia-type illnesses, and
discussed Tonix’s ongoing Phase 2 study of TNX-102 SL in
fibromyalgia-type Long COVID. Symptoms of Long COVID, like
multi-site pain, fatigue and insomnia, are the hallmarks of chronic
pain syndromes like fibromyalgia and CFS/ME.
“The U.S. Department of Health and Human
Services National Research Action Plan on Long COVID1, released in
August 2022, addresses the overlap of Long COVID with CFS/ME,
which, like fibromyalgia, is one of the overlapping chronic pain
syndromes with central sensitization,” said Seth Lederman, M.D.,
Chief Executive Officer of Tonix Pharmaceuticals. “Furthermore, a
recent survey2 found comparable pain, fatigue and function between
Long COVID, fibromyalgia and CFS/ME.”
Enrollment continues in the Phase 2 PREVAIL
study of TNX-102 SL as a potential treatment for patients with Long
COVID syndrome whose symptoms overlap with fibromyalgia. PREVAIL is
a randomized, double-blind, placebo-controlled study in the U.S.
that is expected to enroll approximately 470 patients. One
unblinded interim analysis is anticipated based on the first 50% of
randomized participants.
Dr. Lederman’s presentation is available under
the Presentations tab of the Tonix website at
www.tonixpharma.com.
1Department of Health and Human Services, Office
of the Assistant Secretary for Health. 2022. National Research
Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC
20201.
2Haider S, et al. Pain. 2023;164(2):385-401.
About Solve M.E.
Solve M.E. is a non-profit organization that
serves as a catalyst for critical research into diagnostics,
treatments, and cures for CFS/ME, Long COVID and other
post-infection conditions.
About BIO
BIO is the world’s largest advocacy association
representing member companies, state biotechnology groups, academic
and research institutions, and related organizations across the
United States and in 30+ countries.
About Long COVID or Post-Acute Sequelae
of SARS-CoV-2 (PASC)
Although most people recover from COVID-19
within weeks of the acute illness, a substantial portion develop a
chronic syndrome called Long COVID. These individuals experience a
constellation of symptoms long past the time of recovery from acute
COVID-19. Most Long COVID patients who have been studied appear to
have cleared the SARS-CoV-2 virus from their systems. The symptoms
of Long COVID can include fatigue, sleep disorders, pain, fevers,
shortness of breath, cognitive impairment described as “brain fog”
or memory disturbance, gastrointestinal symptoms, anxiety, and
depression. Long COVID can persist for months and can range in
severity from mild to incapacitating. Several cohort studies have
reported that persistence of symptoms following SARS-CoV-2
infection occurs in approximately 19% of people who recover from
COVID.1 While typically associated with moderate or severe
COVID-19, Long COVID can occur after mild COVID-19 or even after
asymptomatic SARS-CoV-2 infection. Patients with Long COVID are
sometimes referred to as “long-haulers”. Long COVID is a chronic
disabling condition that is expected to result in a significant
global health and economic burden.2 In response to the urgent
need for therapies that address Long COVID, Congress awarded $1.15
billion to the National Institutes of Health to study Long COVID in
December 2021.3 While the vaccines available in the U.S. under
Emergency Use Authorization have been shown to prevent acute COVID,
their ability to prevent Long COVID is unknown. There is currently
no approved drug for the treatment of Long COVID.”
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. 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 second quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
being studied in a potential pivotal Phase 2 study that initiated
enrollment in the first quarter of 2023 and for which interim data
is expected in the fourth 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 second quarter of 2023.
Tonix’s infectious disease pipeline includes a vaccine in
development to prevent smallpox and monkeypox, TNX-801; a
next-generation vaccine to prevent COVID-19, TNX-1850; a platform
to make fully human monoclonal antibodies to treat COVID-19,
TNX-3600; and humanized anti-SARS-CoV-2 monoclonal antibodies,
TNX-3800; and a class of broad-spectrum small molecule oral
antivirals, TNX-3900. 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 the second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm
– Accessed Feb. 21, 2023
2Briggs, Andrew, and Anna Vassall. "Count the
cost of disability caused by COVID-19." (2021): 502-505.
3The NIH provision of Title III Health and Human
Services, Division M--Coronavirus Response and Relief Supplemental
Appropriations Act, 2021, of H.R. 133, The Consolidated
Appropriations Act of 2021. The bill was enacted into law on 27
December 2020, becoming Public Law 116-260.
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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