Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, today
provided an update on the potential impact on the size of the
fibromyalgia market for its development candidate Tonmya (TNX-102
SL or cyclobenzaprine HCl sublingual tablets), based on the new
definition of Long COVID by the U.S. National Academies of
Sciences, Engineering and Medicine (NASEM) announced on June 11,
20241.
“The consensus report from the NASEM concludes
that fibromyalgia is a ‘diagnosable condition’ in people suffering
from Long COVID,” said Seth Lederman, M.D., Chief Executive Officer
of Tonix Pharmaceuticals. “It has long been recognized that
fibromyalgia can arise after a viral illness and is considered an
infection-associated chronic condition.2,3 The NASEM definition
confirms that fibromyalgia occurs after infection with the
SARS-CoV-2 virus in some patients with Long COVID. Tonix is
planning to file a New Drug Application (NDA) for Tonmya in the
second half of this year for the indication of fibromyalgia with
the U.S. Food and Drug Administration (FDA). We believe that
diagnosing fibromyalgia in Long COVID patients will increase the
potential market for Tonmya following approval as compared to
market estimates from before the COVID-19 pandemic.”
Dr. Lederman continued, “Prior to the COVID-19
pandemic, the prevalence of fibromyalgia was estimated to be more
than 10 million adults in the U.S.4 The U.S. Census Bureau,
the National Center for Health Statistics Household Pulse Survey
and the Centers for Disease Control and Prevention (CDC) estimate
that approximately 5.3% of U.S. adults suffer from Long COVID, or
14 million people.5 Fibromyalgia is commonly diagnosed in Long
COVID patients6-8. Although it is unknown how many Long COVID
patients meet the diagnostic criteria for fibromyalgia, the
National Institutes of Health (NIH)-sponsored RECOVER study found
many Long COVID patients suffer from pain at multiple sites9. The
Company has previously presented its analysis of real-world
evidence from the TriNetX claims database suggesting that over 40%
of Long COVID patients present with a constellation of symptoms
that overlap with fibromyalgia.10,11 The Company completed a
proof-of-concept study in Long COVID patients who presented with
multisite pain and found a nominal benefit in fatigue with TNX-102
SL treatment with no new safety signals. We hope this new
definition of Long COVID will allow patients suffering from chronic
pain and other debilitating symptoms to access the care they
need.”
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, non-restorative sleep, fatigue, and brain fog (or
cognitive dysfunction). Other associated symptoms include mood
disturbances, including anxiety and depression, headaches, and
abdominal pain or cramps. 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™ (cyclobenzaprine HCl sublingual tablets)
is a centrally acting, non-opioid, non-addictive, investigational
drug being developed as a daily bedtime medication for the
management of fibromyalgia, alcohol use disorder and agitation in
Alzheimer’s disease. The tablet is a patented sublingual
formulation of cyclobenzaprine hydrochloride TNX-102 SL 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 receptors. 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 TNX-102 SL composition. These
patents are expected to provide TNX-102 SL, upon NDA approval, with
U.S. market exclusivity until 2034/2035. In December 2023, the
company announced highly statistically significant and clinically
meaningful topline results in RESILIENT, the second pivotal 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 six key secondary
endpoints related to improving sleep quality, reducing fatigue and
improving overall fibromyalgia symptoms and function. RELIEF, the
first statistically significant 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.
In both pivotal studies, the most common treatment-emergent adverse
event was tongue or mouth numbness at the administration site,
which was temporally related to dosing, self-limited, never rated
as severe, and rarely led to study discontinuation (one participant
in each study). Tonix has recently announced receipt of the formal
minutes from both recent pre-New Drug Application (NDA) meetings
with the U.S. Food and Drug Administration (FDA) for Tonmya for the
management of fibromyalgia. At these meetings, the Company and the
FDA agreed on the proposed content and timing of an NDA submission.
The Company reaffirmed its guidance to submit the NDA for Tonmya to
the FDA in the second half of 2024 which would allow for a
potential FDA approval in 2025. Tonmya for the management of
fibromyalgia has been granted FDA Fast Track designation.
About the Phase 2 PREVAIL
Study
The Phase 2 PREVAIL study was a 14-week
double-blind, randomized, multicenter, placebo-controlled study to
evaluate the efficacy and safety of TNX-102 SL taken daily at
bedtime in patients with multi-site pain associated with Long
COVID. The trial was conducted at approximately 30 sites in the
U.S. The study was not significant on the primary efficacy endpoint
of the change from baseline in the weekly average of daily
self-reported worst pain intensity scores at the Week 14 endpoint.
Nominal activity of TNX-102 SL was shown in fatigue.
For more information, see ClinicalTrials.gov
Identifier: NCT05472090.
About Long COVID
Long COVID is an infection-associated chronic
condition (IACC) that occurs after SARS-CoV-2 infection and is
present for at least 3 months as a continuous, relapsing and
remitting, or progressive disease state that affects one or more
organ systems. Long COVID is the term widely recognized for the
post-COVID syndrome formerly known as Post-acute sequelae of
COVID-19, or PASC. Although most people recover from COVID-19
within weeks of the acute illness, a substantial portion develops
Long COVID. These individuals experience a constellation of
disabling 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 infection from their systems.
Tonix Pharmaceuticals Holding
Corp.**
Tonix is a fully-integrated biopharmaceutical
company focused on developing, licensing and commercializing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s development portfolio is focused on central
nervous system (CNS) disorders. Tonix’s priority is to submit a New
Drug Application (NDA) to the FDA in the second half of 2024 for
Tonmya, a product candidate for which two statistically significant
Phase 3 studies have been completed for the management of
fibromyalgia. TNX-102 SL is also being developed to treat acute
stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine
esterase), a biologic designed to treat cocaine intoxication that
has Breakthrough Therapy designation. Tonix’s immunology
development portfolio consists of 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. Tonix also
has product candidates in development in the areas of rare disease
and infectious disease. Tonix Medicines, our commercial subsidiary,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute
migraine with or without aura in adults.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration as the tradename for TNX-102 SL for
the management of fibromyalgia. Tonmya has not been approved for
any indication.
**Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1U.S. National Academies of Sciences,
Engineering, and Medicine. 2024. A Long COVID Definition: A
chronic, systemic disease state with profound consequences.
Washington, DC: The National Academies Press.
https://doi.org/10.17226/27768.
http://www.nationalacademies.org/long-covid-definition.2Clauw DJ,
et al. Pain. 2020 161(8):1694–7.3Choutka J, et al. Nat Med. 2022
28(5):911–23.4Vincent A, et al. Arthritis Care Res (Hoboken). 2013
65(5):786-92. doi: 10.10025National Center for Health Statistics.
U.S. Census Bureau, Household Pulse Survey, 2022–2024. Long COVID.
Generated interactively: July 22,
2024 from https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm6Gavrilova,
N, et al. 2022. Pathophysiology 29(1):24-29.
https://doi.org/10.3390/ pathophysiology29010003.7Clauw, DJ, and L
Calabrese. 2024. Annals of the Rheumatic Diseases 83:136-1388Savin,
E., et al. 2023. PLoS One 18(2):e0281593.
https://doi.org/10.1371/journal. pone.0281593.9Thaweethai T, et al.
JAMA. 2023 329(22):1934-1946.10Feb 22, 2023 Tonix Pharmaceuticals
Press Release. URL:
https://ir.tonixpharma.com/news-events/press-releases/detail/1369/tonix-pharmaceuticals-describes-emerging-research-on-the11September
21, 2022, Tonix Pharmaceuticals Poster at the IASP, “Retrospective
observational database study of patients with Long COVID with
multi-site pain, fatigue and insomnia”. URL:
www.tonixpharma.com/wp-content/uploads/2022/09/Retrospective-Observational-Database-Study-of-Patients-with-Long-COVID-with-Multi-Site-Pain-Fatigue-and-Insomnia_A-Real-World-Analysis-of-Symptomatology-and-Opioid-Use.pdf
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, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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
Katie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
Grafico Azioni Tonix Pharmaceuticals (NASDAQ:TNXP)
Storico
Da Lug 2024 a Ago 2024
Grafico Azioni Tonix Pharmaceuticals (NASDAQ:TNXP)
Storico
Da Ago 2023 a Ago 2024