Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced it plans to develop TNX-102 SL (cyclobenzaprine HCl
sublingual tablets) as a potential treatment for Long COVID
Syndrome (Long COVID) which is now known officially as Post-Acute
Sequelae of COVID-19 (PASC1). Tonix plans to meet with the U.S.
Food and Drug Administration (FDA) in the third quarter of 2021 to
seek agreement on the design of a potential Phase 2 pivotal study
and the overall clinical development plan to qualify TNX-102 SL as
an indicated treatment for Long COVID.
Although most people recover from COVID-19
within weeks of the acute illness, a substantial portion develop a
chronic syndrome called Long COVID, or PASC. 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”, 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 more than 30% of patients.2 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.
Seth Lederman, M.D., President and Chief
Executive Officer of Tonix, stated, “We are excited to begin
development of TNX-102 SL for the treatment of Long COVID because
the program leverages what we have learned about the
pharmacodynamic activity of TNX-102 SL from more than one thousand
participants who have been or are enrolled in our fibromyalgia
trials to date. Long COVID has been compared to fibromyalgia
because of the common symptoms of sleep disturbance, persistent
pain, fatigue, and brain fog.3 Additionally, Long COVID, like
fibromyalgia, is experienced by women at a rate approximately four
times that of men.4 The 2003 SARS outbreak that was due to an
earlier coronavirus outbreak was also described as causing a
post-SARS syndrome similar to fibromyalgia.5 Long COVID is a
chronic disabling condition that is expected to result in a
significant global economic burden.6 In response to the urgent need
for therapies that address PASC, Congress awarded $1.15 billion to
the National Institutes of Health to study Long COVID last
December.7 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 PASC.”
Gregory Sullivan, M.D., Chief Medical Officer of
Tonix, commented, “We believe the core symptoms of Long COVID,
including fatigue, sleep disturbances, and persistent pain, share
an underlying pathogenesis with fibromyalgia. By improving sleep
quality, we believe TNX-102 SL may improve the sleep disturbance of
Long COVID and potentially also improve other symptoms of Long
COVID. For example, TNX-102 SL showed activity in addressing
persistent pain, sleep disturbance and fatigue in our fibromyalgia
Phase 3 study. In our double-blind clinical studies for
both fibromyalgia and posttraumatic stress disorder (PTSD), TNX-102
SL showed robust activity in improving sleep quality starting
within the first two weeks of treatment.”
Dr. Lederman added, “TNX-102 SL is in mid-Phase
3 development for the treatment of fibromyalgia, for which interim
analysis results of the second potential pivotal study are expected
in the third quarter of 2021, and topline results are expected in
the first quarter of 2022. The proposed mechanism of TNX-102 SL is
to improve sleep quality. Since disturbed sleep is linked to
exacerbation and chronicity of a number of pain, neuropsychiatric
and addictive disorders, we plan to conduct clinical trials to
determine whether TNX-102 SL improves sleep in certain pain and
neuropsychiatric disorders in addition to fibromyalgia. Tonix
already has four active INDs for TNX-102 SL, including
fibromyalgia, PTSD, agitation in Alzheimer’s disease (AAD) and
alcohol use disorder (AUD).”
1Feb. 24, 2021 - White House COVID-19 Response Team press
briefing; Feb 25, 2021 - policy brief from the World Health
Organization on long COVID
2Nalbandian, Ani, et al. "Post-acute COVID-19
syndrome." Nature Medicine (2021): 1-15.
3Clauw DJ, Häuser W, Cohen SP, Fitzcharles M-A. Considering the
potential for an increase in chronic pain after the COVID-19
pandemic. Pain. 2020 Aug; 161(8): 1694–1697.
4Cox, D. “Why are women more prone to long Covid?” The
Guardian. 13 Jun 2021
https://www.theguardian.com/society/2021/jun/13/why-are-women-more-prone-to-long-covid
5Moldofsky H, Patcai J. Chronic widespread musculoskeletal pain,
fatigue, depression and disordered sleep in chronic post-SARS
syndrome; a case-controlled study. BMC Neurol 2011;11:37.
6Briggs, Andrew, and Anna Vassall. "Count the cost of disability
caused by COVID-19." (2021): 502-505.
7The 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.
About Long COVID or Post-Acute Sequelae
of SARS-CoV-2 (PASC)
Long COVID is a protracted syndrome experienced
by some people following SARS-CoV-2 infection, that can include a
number of persistent symptoms including fatigue, pain, sleep
disturbance, brain fog or difficulty concentrating, arthralgias,
olfactory dysfunction, and headache. Patients with Long COVID are
sometimes referred to as “long-haulers.”
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 serotonin2A, α1-adrenergic,
histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in
clinical development as a daily bedtime treatment for fibromyalgia,
PTSD, alcohol use disorder and agitation in Alzheimer’s disease.
The U.S. Patent and Trademark Office (USPTO) has 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 these patents 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
small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix’s portfolio is primarily composed of
central nervous system (CNS) and immunology product candidates. The
Company’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3
development for the management of fibromyalgia, with positive data
from the Phase 3 RELIEF study reported in December 2020. The
Company expects interim data from the second Phase 3 study, RALLY,
in the third quarter of 2021 and topline data in the first quarter
of 2022. Tonix’s immunology portfolio includes vaccines to prevent
infectious diseases and biologics to address immunosuppression,
cancer, and autoimmune diseases. Tonix’s lead vaccine candidate,
TNX-18002, is a live replicating vaccine based on the horsepox
viral vector platform to protect against COVID-19, primarily by
eliciting a T cell response. Tonix reported positive efficacy data
from animal studies of TNX-1800 in the first quarter of 2021.
TNX-8012, live horsepox virus vaccine for percutaneous
administration, is in development to protect against smallpox and
monkeypox.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.2TNX-1800 and TNX-801 are
investigational new 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 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, 2020, as filed with the Securities and
Exchange Commission (the “SEC”) on March 15, 2021, and periodic
reports filed with the SEC on or after the date thereof. All
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)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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