Tonix Pharmaceuticals Announces Results of Retrospective Observational Database Study In Over 50,000 Long COVID Patients
April 20 2022 - 6:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, announced today the
results of a retrospective observational database study in over
50,000 patients diagnosed with Long COVID1-2. Long COVID is known
officially as Post-Acute Sequelae of COVID-19 (PASC3). Tonix
recently announced that the U.S. Food and Drug Administration (FDA)
has cleared the Investigational New Drug (IND) application to
support a Phase 2 clinical trial with TNX-102 SL4 (cyclobenzaprine
HCl tablets for sublingual administration) as a potential treatment
for a subset of patients with Long COVID whose symptoms overlap
with fibromyalgia, and expects to initiate this study in the second
quarter. The goal of the retrospective database study was to assess
the proportion of Long COVID patients who experience
fibromyalgia-like multi-site pain and to measure their use of
opiates.
In the study, over 40% of patients with symptoms
of Long COVID had fibromyalgia-like multi-site pain 1,2. In
addition, the study reported on the rate of opioid use in Long
COVID patients. Opioid use noted was in 36% of Long COVID patients
with multi-site pain symptoms relative to 19% of Long COVID
patients without multi-site pain. In patients with multisite pain,
opiate use increased to 39% of patients when fatigue was present,
and 50% of patients when insomnia was present.
“We undertook this retrospective analysis in
part to determine the feasibility and representative nature of our
upcoming Phase 2 study of TNX-102 SL in patients with Long COVID
who present with fibromyalgia-like multi-site pain,” said Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
“The finding that more than 40% of Long COVID patients in this
sample have fibromyalgia-like multi-site pain symptoms suggests
that we should be able to recruit a robust cohort of participants
to test the effects of TNX-102 SL in treating this condition.
Further, these findings suggest that the group of Long COVID
patients with fibromyalgia-like multi-site pain represents a
significant portion of this underserved population. Finally, the
high level of opiate use reveals the urgency to provide effective
non-opioid analgesia that is targeted toward widespread pain
thought to be nociplastic in nature, meaning that augmented CNS
pain and sensory processing, as well as altered pain modulation,
play a role. The primary efficacy endpoint of the upcoming Phase 2
study will therefore be change from baseline in the weekly average
of daily self-reported worst pain intensity scores.”
The study queried data from the TriNetX
Dataworks USA Network. The network is a federated network of
de-identified inpatient and outpatient electronic medical records
from 48 U.S. healthcare organizations. From 75 million people in
the network, approximately 1 million adults (18-65) had been
diagnosed with acute COVID-19. Of these, approximately 260,000
followed up with a healthcare provider in the network within six
months of having acute COVID-19. Of these, approximately 52,000 had
Long COVID symptoms in the period between 3 and 6 months after
acute COVID-19, which was the time-frame for the analysis for
diagnostic codes consistent with multi-site pain, fatigue and
insomnia.
1Harris, H, et al. Tonix data on file. 20222TriNetX
Analytics3Feb. 24, 2021 - White House COVID-19 Response Team press
briefing; Feb 25, 2021 - policy brief from the World Health
Organization on long COVID.4TNX-102 SL is an investigational new
drug and has not been approved for any indication.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics and diagnostics to treat and prevent human disease and
alleviate suffering. Tonix’s portfolio is composed of immunology,
rare disease, infectious disease, and central nervous system (CNS)
product candidates. Tonix’s immunology portfolio includes biologics
to address organ transplant rejection, autoimmunity and cancer,
including TNX-15001 which is a humanized monoclonal antibody
targeting CD40-ligand 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 half of 2022. Tonix’s rare disease
portfolio includes TNX-29002 for the treatment of Prader-Willi
syndrome. TNX-2900 has been granted Orphan-Drug Designation by the
FDA. Tonix’s infectious disease pipeline includes a vaccine in
development to prevent smallpox and monkeypox called TNX-8013,
next-generation vaccines to prevent COVID-19, and an antiviral to
treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are
TNX-1840 and TNX-18504, which are live virus vaccines based on
Tonix’s recombinant pox vaccine (RPV) platform.
TNX-35005 (sangivamycin, i.v. solution) is a small molecule
antiviral drug to treat acute COVID-19 and is in the pre-IND stage
of development. TNX-102 SL, (cyclobenzaprine HCl sublingual
tablets), is a small molecule drug being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix expects to
initiate a Phase 2 study in Long COVID in the second quarter of
2022. 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 SL, is in mid-Phase
3 development for the management of fibromyalgia with a new Phase 3
study launched in the second quarter of 2022. Finally, TNX-13006 is
a biologic designed to treat cocaine intoxication that is expected
to start a Phase 2 trial in the second quarter of 2022.
1TNX-1500 is an investigational new biologic at
the pre-IND stage of development and has not been approved for any
indication.2TNX-2900 is an investigational new drug at the pre-IND
stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox virus vaccine for percutaneous
administration in development to protect against smallpox and
monkeypox. TNX-801 is an investigational new biologic and has not
been approved for any indication.4TNX-1840 and TNX-1850 are live
horsepox virus vaccines for percutaneous administration, in
development to protect against COVID-19. TNX-1840 and TNX-1850 are
designed to express the SARS-CoV-2 spike protein from the omicron
and BA.2 variants, respectively. TNX-1840 and TNX-1850 are
investigational new biologics at the pre-IND stage of development
and have not been approved for any indication. 5TNX-3500 is an
investigational new drug at the pre-IND stage of development and
has not been approved for any indication.6TNX-1300 is an
investigational new biologic and has not been approved for any
indication.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
About TriNetX, LLC
TriNetX is a global health research network that
connects the world of drug discovery and development from
pharmaceutical company to study site, and investigator to patient
by sharing real-world data to make clinical and observational
research easier and more efficient. TriNetX combines real time
access to longitudinal clinical data with state-of-the-art
analytics to optimize protocol design and feasibility, site
selection, patient recruitment, and enable discoveries through the
generation of real-world evidence. The TriNetX platform is HIPAA
and GDPR compliant.
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) 799-8599
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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