Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announces a poster
presentation at the American Chemistry Society (ACS) Spring 2024
Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy
of the poster is available under the scientific presentations page
of the Tonix website at www.tonixpharma.com.
The poster presentation titled, Oxytocin Analogs
with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium
Formulations, describes the discovery and characterization of novel
oxytocin analogues that are candidate treatments for craniofacial
pain, excessive eating (including Prader Willi Syndrome), and
endocrinological conditions including bone health in autism and
insulin resistance.
“Intranasal oxytocin has several potential
therapeutic applications,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “Preclinical studies
have shown that oxytocin, a hypothalamic peptide hormone,
simultaneously reduces food intake and increases energy
expenditure, leading to weight loss.1-3 Intranasal oxytocin is
well-tolerated and in published studies of adults, results in
reduced caloric intake, increased fat burning and improved insulin
sensitivity.1-3”
Dr. Lederman continued, “There is preclinical
evidence that the activity of intranasal oxytocin is dependent on
magnesium (Mg++) concentration.4-6 Our current intranasal
oxytocin formulations of TNX-1900 and TNX-2900 contain Mg++ to
augment the activity. We believe the new oxytocin analogues
described in the poster have enhanced binding to Mg++ and
consequently their activity does not require Mg++
augmentation.”
Four Phase 2 investigator-initiated studies of
TNX-1900 are currently ongoing; three at the Massachusetts General
Hospital (MGH) and one at the University of Washington. The Phase 2
‘POWER’ study at MGH is investigating the efficacy and safety of
TNX-1900 as a novel therapeutic agent to induce weight loss and
improve indicators of cardiometabolic risk in adolescent patients
with obesity. The Phase 2 ‘STROBE’ study at MGH is investigating
the efficacy and safety of TNX-1900 as a novel therapeutic agent to
reduce binge eating frequency in adults with binge-eating disorder.
The Department of Defense (DoD)-funded Phase 2 ‘BOX’ study at MGH
is investigating the efficacy and safety of TNX-1900 as a novel
therapeutic agent to improve bone health in children with autism
spectrum disorder. In addition, a Phase 2 study at the University
of Washington is investigating the potential role of TNX-1900 in
enhancing vicarious extinction learning in social anxiety disorder,
compared to healthy controls.
About TNX-1900 and TNX-2900
TNX-1900 and TNX-2900 (intranasal potentiated
oxytocin) are proprietary formulations of oxytocin. TNX-1900 is in
Phase 2 development under investigator-initiated INDs as a
candidate for adolescent obesity, binge eating disorder, bone
health in autism and social anxiety disorder. TNX-1900 is also
planned for development in treating insulin resistance. TNX-2900 is
in development as a treatment for Prader Willi Syndrome. TNX-2900
has received orphan drug designation from the U.S. Food and Drug
Administration (FDA) and its IND has been cleared. 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 nasal
cavity. Tonix’s patented intranasal potentiated oxytocin
formulation intended for use by adults and adolescents. Tonix’s
patented potentiated oxytocin formulation is believed to increase
specificity for oxytocin receptors relative to vasopressin
receptors as well as to enhance the potency of oxytocin. Oxytocin
is a naturally occurring human hormone that acts as a
neurotransmitter in the brain. Oxytocin is believed to be more than
600 million years old and is present in vertebrates including
mammals, birds, reptiles, amphibians and fish.7 It was originally
approved by the U.S. Food and Drug Administration as Pitocin®*, an
intravenous infusion or intramuscular injection drug, for use in
pregnant women to induce labor. An intranasal formulation of
oxytocin is marketed in some European countries to assist in the
production of breast milk as Syntocinon®** (oxytocin nasal 40
units/ml). Oxytocin has no recognized addiction potential.
Oxytocin, when delivered via the nasal route, concentrates in the
trigeminal system1 resulting in binding of oxytocin to receptors on
neurons in the trigeminal system. With TNX-1900 and TNX-2900, the
addition of magnesium to the oxytocin formulation enhances oxytocin
receptor binding8 as well as its inhibitory effects on trigeminal
neurons and resultant craniofacial analgesic effects, as
demonstrated in animal models9. Intranasal oxytocin has been shown
to be well tolerated in several clinical trials in both adults and
children10. Targeted nasal delivery results in low systemic
exposure and lower risk of non-nervous system, off-target effects.
Tonix also has a license with the University of Geneva to use
TNX-1900 for the treatment of insulin resistance and related
conditions.
About Prader-Willi Syndrome
(PWS)
PWS is recognized as the most common genetic
cause of life-threatening childhood obesity and affects males
and females with equal frequency and all races and ethnicities. PWS
results from the absence of expression of a group of genes on the
paternally acquired chromosome 15. The hallmarks of PWS are
lack of suckling in newborns and, in children and adolescents,
severe hyperphagia, an overriding physiological drive to eat,
leading to severe obesity and other complications associated with
significant mortality. A systematic review of the morbidity and
mortality as a consequence of hyperphagia in PWS found that the
average age of death in PWS was 22.1 years.11 There is no approved
medication to treat poor feeding in newborns or hyperphagia in
children and adolescents with PWS. Given these serious or
life-threatening manifestations of these conditions, there is a
critical need for effective treatments to decrease morbidity and
mortality, improve quality of life, and increase life expectancy in
people with PWS. Oxytocin has potent effects in adult mice
correcting behavioral characteristics of the Magel2 knock-out mouse
model for PWS and autism.12 In addition, oxytocin has potent
effects in correcting behavioral characteristics of the neonatal
Magel2 knock-out mouse model for PWS and autism13 and
intriguing effects in a clinical trial of neonates with PWS.14
*Pitocin® is a trademark of Par Pharmaceutical,
Inc.
**Syntocinon® is a trademark of BGP Products
Operations GmbH
References
1Lawson EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi:
10.1111/jne.12805.2Niu J, et al. Front Neurosci 2021;15:743546.
doi: 10.3389/fnins.2021.743546.3Maejima Y, et al.
Neuroendocrinology 2018;107(1):91-104.4Yeomans DC, et al. Transl
Psychiatry. 2021. 11(1):388.5Tzabazis A, et al. Cephalalgia. 2016.
36(10):943-50.6Meyerowitz JG, et al. Nat Struct Mol Biol. 2022.
29(3):274-281.7Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi:
10.1113/expphysiol.2013.072561.8Antoni FA and Chadio SE. Biochem J.
1989. 257(2):611-4.9Cai Q, et al., Psychiatry Clin Neurosci. 2018.
72(3):140-151.10Yeomans, DC et al. 2017. US patent
US2017368095.11Bellis SA, et al. Eur J Med Genet. 2022.
65(1):104379.12Meziane H, et al. Biol Psychiatry. 2015.
78(2):85-94.13Bertoni A, et al. Mol Psychiatry. 2021.
26(12):7582-7595.14Tauber M, et al. Pediatrics. 2017.
139(2):e20162976.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a 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 positive Phase 3 studies have been completed for the
management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction as well as fibromyalgia-type Long
COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a
biologic designed to treat cocaine intoxication with 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.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication. Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration as the tradename for TNX-102 SL for
the management of fibromyalgia.
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, 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 ContactJessica
MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media ContactBen ShannonICR
Westwickeben.shannon@westwicke.com(919) 360-3039
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