Tonix Pharmaceuticals Presents Data from Retrospective Observational Database Study on the Incidence of Multi-Site Pain Symptoms in Long COVID Patients at IASP 2022 World Congress on Pain
September 22 2022 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced data from a retrospective observational database study in
patients diagnosed with Long COVID at the International Association
for the Study of Pain (IASP) 2022 World Congress on Pain, being
held September 20-23, 2022, in Toronto, Canada. The study was
motivated to identify the frequency of symptoms of multi-site pain,
fatigue and insomnia in Long COVID patients because these are the
hallmarks of Overlapping Chronic Pain Syndromes like fibromyalgia
and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). A
copy of the poster is available under the Scientific Presentations
tab of the Tonix website at www.tonixpharma.com.
The poster presentation titled, “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,” include data from the study showing
that:
- Approximately
40% of patients with symptoms of Long COVID had fibromyalgia-like
multi-site pain.
- The rate of
opioid use in Long COVID patients with multi-site pain was 34%,
compared to 19% of Long COVID patients without multi-site
pain.
- In patients
with multi-site pain, opioid use increased to approximately 50% of
patients when sleep disturbance was also present.
“The recently released U.S. HHS National
Research Action Plan on Long COVID1 repeatedly addresses the
overlap of Long COVID with ME/CFS, 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. “Previously, central sensitization had
been observed in approximately two-thirds of Long COVID patients2.
The data from the new retrospective study revealed that U.S. Long
COVID patients are turning to opioids for symptomatic relief,
revealing the urgency to provide effective non-opioid,
non-addictive analgesics that address multi-site pain. Currently,
there is no therapy approved by the U.S. Food and Drug
Administration for the treatment of multi-site pain associated with
Long COVID.”
In August 2022, the Company announced that the
first participant was enrolled in the Phase 2 PREVAIL study of
TNX-102 SL as a potential treatment for patients with Long COVID
syndrome (Long COVID) whose symptoms overlap with fibromyalgia.
Long COVID is known officially as Post-Acute Sequelae of COVID-19
(PASC).
Dr. Lederman added, “TNX-102 SL is a
centrally-acting non-opioid analgesic with no recognized abuse
potential that has shown to decrease daily pain in a Phase 3 study
of fibromyalgia. The finding that approximately 40% of Long COVID
patients have fibromyalgia-like multi-site pain symptoms in the
retrospective observational database study suggests that we should
be able to recruit a robust cohort of participants to test the
effects of TNX-102 SL in treating multi-site pain in Long COVID in
our ongoing Phase 2 study.”
Citations
1U.S. Department of Health and Human Services,
August 9, 2022. “National Research Action Plan on Long COVID”.
www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf.
2Goudman, L, et al. J of Clin Med.
2021;10(23):5594. https://doi.org/10.3390/jcm10235594
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 and
expects interim data in the first half 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 2023. TNX-1900 (intranasal potentiated oxytocin), a
small molecule in development for chronic migraine, is expected to
enter the clinic with a Phase 2 study in the fourth quarter of
2022. 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 first half of 2023. Tonix’s infectious disease pipeline
consists of a vaccine in development to prevent smallpox and
monkeypox, next-generation vaccines to prevent COVID-19, and a
platform to make fully human monoclonal antibodies to treat
COVID-19. 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 Kenya in the first half of 2023. Tonix’s lead vaccine
candidate for COVID-19 is TNX-1850, a live virus vaccines based on
Tonix’s recombinant pox live virus vector vaccine platform. A Phase
1 study of the COVID-19 vaccine 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.
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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