Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that it received the official minutes from a Type B
pre-Investigational New Drug Application (IND) meeting with the
U.S. Food and Drug Administration (FDA) to develop TNX-102 SL1
(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 (PASC2). Tonix believes the
minutes provide a path to agreement on the design of a Phase 2
study and the overall clinical development plan to qualify TNX-102
SL as an indicated treatment for a subset of patients affected by
Long COVID. Based on the minutes, the Company is planning to submit
the IND in the fourth quarter of 2021 to support a Phase 2 study
for the management of a subset of Long COVID patients whose
symptoms overlap with fibromyalgia.
Seth Lederman, M.D., President and Chief
Executive Officer of Tonix, stated, “Long COVID is a new, complex
and heterogeneous disorder. Long COVID is a protracted syndrome
experienced by many people following SARS-CoV-2 infection that can
include a number of persistent disabling symptoms, including
fatigue, widespread pain, sleep disturbance, brain fog or
difficulty concentrating, arthralgias, diffuse myalgia, olfactory
dysfunction, and headache.3 Our Phase 2 study will focus on Long
COVID patients whose primary symptoms overlap with fibromyalgia,
and, therefore, our Long COVID program leverages what we have
learned about the pharmacodynamic activity of TNX-102 SL from more
than 1,000 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 widespread pain, fatigue, and brain fog.4 Additionally,
Long COVID, like fibromyalgia, is experienced by women at a rate
approximately four times that of men.5 The 2003 SARS outbreak, due
to an earlier coronavirus, was also described as causing a
post-SARS syndrome similar to fibromyalgia.6”
Gregory Sullivan, M.D., Chief Medical Officer of
Tonix, commented, “Based on our positive fibromyalgia Phase 3
RELIEF study in which TNX-102 SL showed activity in addressing
persistent pain, sleep disturbance, memory, fatigue and energy, we
are hopeful that TNX-102 SL might provide a unique treatment
opportunity for the symptoms of Long COVID in patients whose
symptoms overlap with those of fibromyalgia. We believe the core
symptoms of Long COVID, including fatigue, sleep disturbances,
persistent pain and diffuse myalgia share an underlying
pathogenesis with fibromyalgia.”
Dr. Lederman added, “TNX-102 SL is in mid-Phase
3 development for the treatment of fibromyalgia. 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 of these other disorders in addition to Long COVID
and fibromyalgia.”
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 more than 30% of patients.3 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.7 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 last December.8 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.”
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.
About 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. 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-18009, 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-8019, live horsepox
virus vaccine for percutaneous administration, is in development to
protect against smallpox and monkeypox. TNX-350010 (sangivamycin)
is a small molecule antiviral drug for COVID-19 in the pre-IND
stage of development.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.
2Feb. 24, 2021 - White House COVID-19 Response
Team press briefing; Feb 25, 2021 - policy brief from the World
Health Organization on long COVID.
3Nalbandian, Ani, et al. "Post-acute COVID-19
syndrome." Nature Medicine (2021): 1-15.
4Clauw 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.
5Cox, 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
6Moldofsky 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.
7Briggs, Andrew, and Anna Vassall. "Count the cost of disability
caused by COVID-19." (2021): 502-505.
8The 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.
9TNX-1800 and TNX-801 are investigational new
biologics at the pre-IND stage of development and have not been
approved for any indication.
10TNX-3500 is an investigational new drug at the
pre-IND stage of development and has 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, the 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.
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)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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