Tonix Pharmaceuticals Announces Presentation of Non-Clinical Studies Supporting the Mechanism of TNX-1900 (Intranasal Potentiated Oxytocin) at the 2023 International Headache Congress
18 Setembro 2023 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced that David C.
Yeomans, Ph.D. presented data relevant to the proposed mechanism of
TNX-1900 (intranasal potentiated oxytocin) in treating chronic
migraine in a poster and an oral presentation at the 2023
International Headache Congress (IHC), being held September 14-17,
2023, in Seoul, South Korea. The poster and oral presentation
titled, "Human trigeminal ganglia possess oxytocin receptors on
CGRP positive neurons: expression increased by inflammation,"
include research sponsored by and licensed to Tonix
Pharmaceuticals. Professor Yeomans was a founder of Trigemina,
which Tonix acquired, and he remains a consultant to Tonix. A copy
of the poster is available under the Scientific Presentations tab
of the Tonix Pharmaceuticals corporate website at
www.tonixpharma.com.
The presentations show that oxytocin receptors
are co-expressed with calcitonin gene-related peptide (CGRP) on
human trigeminal ganglia neurons, which is similar to Professor
Yeomans’ previous findings in animal trigeminal ganglia. The
inflammatory cytokine IL-6 upregulated expression of oxytocin
receptors on human trigeminal neurons, consistent with the
previously observed impact of inflammation on the potency of
oxytocin. In animals, oxytocin has been shown to functionally
inhibit the excitability of trigeminal neurons, which is consistent
with oxytocin inhibiting the release of CGRP at trigeminal nerve
terminals.1
“In animal studies, oxytocin has been shown to
inhibit trigeminal neurons which we believe relates to its
mechanism in preventing migraines,”1 said Seth Lederman, M.D.,
Chief Executive Officer of Tonix Pharmaceuticals. “The data
presented at 2023 IHC by Professor Yeomans shows that oxytocin
receptors are present on human trigeminal ganglia neurons, and that
these same neurons express CGRP, a key peptide in the pathogenesis
of migraine. These data support the proposed mechanism of TNX-1900,
which we believe inhibits the release of CGRP from trigeminal
neurons that otherwise would trigger a cascade leading to
migraine.”
“Similar to animals, human trigeminal ganglia
neurons express oxytocin receptors and also co-express CGRP,” said
Professor Yeomans. “In addition, the inflammatory mediator IL-6
induces robust upregulation of oxytocin receptors on human
trigeminal ganglia neurons. In the presence of inflammation, which
is persistently present in chronic migraine, there is a robust
increase in the expression of both oxytocin receptors and CGRP in
human trigeminal neurons.”
In February 2023, Tonix initiated enrollment in
the Phase 2 ‘PREVENTION’ study of TNX-1900 for the prevention of
migraine headache in chronic migraineurs. Topline results from the
study are expected in the fourth quarter of 2023. In addition,
TNX-1900 is also being evaluated in investigator-initiated Phase 2
trials in adolescent obesity (initiated July 2023), binge eating
disorder and social anxiety disorder.
- Tzabazis A, et
al. Cephalalgia. 2016. 36(10):943-50.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets
Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg under a transition
services agreement with Upsher-Smith Laboratories, LLC from whom
the products were acquired on June 30, 2023. Zembrace SymTouch and
Tosymra are each indicated for the treatment of acute migraine with
or without aura in adults. Tonix’s development portfolio is
composed of central nervous system (CNS), rare disease, immunology
and infectious disease product candidates. Tonix’s CNS development
portfolio includes both small molecules and biologics to treat
pain, neurologic, psychiatric and addiction conditions. Tonix’s
lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl
sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia, having completed enrollment of a
potentially confirmatory Phase 3 study in the third quarter of
2023, with topline data expected in the fourth quarter of 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition. Topline results
from a proof-of-concept Phase 2 study were reported in the third
quarter of 2023. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily oral formulation being
developed as a treatment for major depressive disorder (MDD), that
completed enrollment in a Phase 2 proof-of-concept study in the
third quarter of 2023, with topline results expected in the fourth
quarter of 2023. TNX-4300 (estianeptine) is a single isomer version
of TNX-601, a small molecule oral therapeutic in preclinical
development to treat MDD, Alzheimer’s disease and Parkinson’s
disease. Relative to tianeptine, estianeptine lacks activity on the
µ-opioid receptor while maintaining activity in the rat Novel
Object Recognition test in vivo and the ability to activate
PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900
(intranasal potentiated oxytocin), is in development for preventing
headaches in chronic migraine, and has completed enrollment in a
Phase 2 proof-of-concept study with topline data expected in the
fourth quarter of 2023. TNX-1900 is also being studied in binge
eating disorder, pediatric obesity and social anxiety disorder by
academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development
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 development
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 rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases. The infectious disease development portfolio also
includes TNX-3900 and TNX-4000, which are classes of broad-spectrum
small molecule oral antivirals.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. 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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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
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360-3039
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