Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, announced today that the
European Patent Office (EPO) issued European Patent No. 3242676 to
the Company on October 4, 2023. The patent, entitled
“Magnesium-Containing Oxytocin Formulations and Methods of Use”,
claims methods and compositions for treating pain, including
migraine headaches, using intranasal magnesium-containing oxytocin
formulations. This patent, excluding possible patent term
extensions, is expected to provide Tonix with market exclusivity in
the member states of the European Patent Office until 2036. The
U.S. Patent and Trademark Office (USPTO) has previously issued U.S.
Patents No. 9,629,894 and 11,389,473 which are expected to provide
market exclusivity in the U.S. until 2036.
In August 2023, Tonix announced it completed
enrollment in its proof-of-concept Phase 2 PREVENTION study of
TNX-1900 (intranasal potentiated oxytocin) for the prevention of
migraine headache in chronic migraineurs with a total of 88
patients enrolled. The Company expects topline results from this
trial in early December 2023.
“We believe this European patent combined with
the U.S. issuance provides a strong patent position for TNX-1900 as
we move forward in clinical development for the treatment of
chronic migraine,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “With a differentiated
formulation including magnesium, which Tonix has shown to
potentiate the action of oxytocin at oxytocin receptors in animal
models, we believe TNX-1900 has the potential to help those chronic
migraine sufferers by engaging and stimulating oxytocin receptors
in the trigeminal ganglia. By expanding our patent coverage in
Europe, we are ensuring the IP protection of this unique
approach.”
In addition to Tonix’s patents that protect
certain uses including treating migraine, Tonix has licensed
patents from INSERM, the French national health and medical
research institute, that claim methods of treating feeding
disorders with onset during neonatal development, specifically
Prader Willi syndrome and non-organic failure to thrive (NOFTT),
using oxytocin (EP 2575853, US8853158 and US9125862) and licensed
patents from University of Geneva that claim methods of treating
insulin resistance using oxytocin (US9101569 and EP2571511).
About Migraine
Migraine is a neurological condition that
manifests in throbbing headache, often on one side of the head,
that lasts at least four hours. It can also be accompanied by
nausea, vomiting, visual disturbances, and sensitivity to bright
light, strong smells, and loud noises.1 Epidemiological studies
indicate that globally, approximately 1.2 billion individuals
suffer from migraines annually.2 In the U.S., approximately 39
million Americans suffer from migraines and among these
individuals, approximately four million experience chronic
migraines (15 or more headache days per month).2
About TNX-1900
TNX-1900 (intranasal potentiated oxytocin) is a
proprietary formulation of oxytocin in development as a candidate
for prophylaxis of chronic migraine and for the treatment of
craniofacial pain, insulin resistance and related conditions. In
2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed
the technology underlying the composition and method from Stanford
University. TNX-1900 is a drug-device combination product, based on
an intranasal actuator device that delivers oxytocin into the nose.
Oxytocin is a naturally occurring human hormone that acts as a
neurotransmitter in the brain. Oxytocin has no recognized addiction
potential. It has been observed that low oxytocin levels in the
body can lead to an increase in migraine headache frequency, and
that increased oxytocin levels can relieve migraine headaches.
Certain other chronic pain conditions are also associated with
decreased oxytocin levels. Migraine attacks are caused, in part, by
the activity of pain-sensing trigeminal nerve cells which, when
activated, release of the calcitonin gene-related peptide (CGRP)
which binds to receptors on other nerve cells and starts a cascade
of events that is believed to result in headache. Oxytocin, when
delivered via the nasal route, concentrates in the trigeminal
system3 resulting in binding of oxytocin to receptors on neurons in
the trigeminal system, inhibiting transmission of pain signals and
releasing of the CGRP.4 Blocking CGRP release is a distinct
mechanism compared with CGRP antagonist and anti-CGRP antibody
drugs, which block the binding of CGRP to its receptor. With
TNX-1900, the addition of magnesium to the oxytocin formula
enhances oxytocin receptor binding5, its effects on trigeminal
neurons, and its craniofacial analgesic effects in animal models.7
Intranasal oxytocin has been shown to be well tolerated in several
clinical trials in both adults and children.6 Targeted nasal
delivery results in low systemic exposure and lower risk of
non-nervous system, off-target effects, which could potentially
occur with systemic CGRP antagonists such as anti-CGRP antibodies.8
For example, CGRP has roles in dilating blood vessels in response
to ischemia, including in the heart. We believe nasally targeted
delivery of oxytocin could translate into selective blockade of
CGRP release in the trigeminal ganglion and not throughout the
body, which could be a potential safety advantage over systemic
CGRP inhibition. In addition, daily dosing is more quickly
reversible, in contrast to monthly or quarterly dosing, as is the
case with anti-CGRP antibodies, giving physicians and their
patients greater control.
-
https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201
- Burch et al.,
Migraine: Epidemiology, Burden, and Comorbidity, Neurol Clin 37
(2019) 631–649.
- Yeomans DC, et
al. Transl Psychiatry. 2021. 11(1):388.
- Tzabazis A, et
al. Cephalalgia. 2016. 36(10):943-50.
- Antoni FA and
Chadio SE. Biochem J. 1989. 257(2):611-4.
- Yeomans, DC et
al. 2017. US patent US2017368095
- Cai Q, et al.,
Psychiatry Clin Neurosci. 2018. Mar;72(3):140-151.
-
MaassenVanDenBrink A, et al. Trends Pharmacol Sci. 2016.
37(9):779-788
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 late December 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition. Enrollment in a
Phase 2 proof-of-concept study has been completed, and topline
results 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 early November of 2023. TNX-4300 (estianeptine)
is a single isomer version of TNX-601, 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 early December 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
Ben ShannonICR Westwickeben.shannon@westwicke.com(919)
360-3039
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