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TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals Announces
Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024
Four Phase 2 investigator-initiated
studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism
and social anxiety disorder
TNX-2900 (intranasal potentiated
oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating
TNX-1900 and TNX-2900 may serve
as novel neuroendocrine treatments for certain pain, eating and endocrine disorders
CHATHAM, N.J., March 21, 2024 - 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
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++
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
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
*Pitocin is a trademark of Par Pharmaceutical,
**Syntocinon is a trademark of BGP
Products Operations GmbH
EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi: 10.1111/jne.12805.
J, et al. Front Neurosci 2021;15:743546. doi: 10.3389/fnins.2021.743546.
Y, et al. Neuroendocrinology 2018;107(1):91-104.
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Psychiatry. 2021. 11(1):388.
5Tzabazis A, et al. Cephalalgia.
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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
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