Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Announces Collaboration
with Massachusetts General Hospital to Evaluate TNX-1900 (Intranasal Potentiated Oxytocin) for Treating Binge Eating Disorder
An Investigator Initiated Phase 2 Clinical
Trial of TNX-1900 In Patients with Binge Eating Disorder Planned for Second Half 2022
Binge Eating Disorder is Estimated to Affect
2.8 Million American Adults1-3
Expands Uses of Tonix's Proprietary
Potentiated Oxytocin for Intranasal Administration to a Potential New Indication
CHATHAM, N.J., March 7, 2022 (GLOBE NEWSWIRE)
- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
an agreement with Massachusetts General Hospital, a teaching hospital of Harvard Medical School, to evaluate TNX-1900* in an investigator
initiated Phase 2 clinical trial as a potential treatment for patients with binge eating disorder. The Phase 2 clinical trial is expected
to start in the second half of 2022.
"Binge eating disorder is a serious mental
health condition associated with behavioral and metabolic morbidity for which there are few treatment options," said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Oxytocin is a well-known natural hormone that is used therapeutically in
certain other indications including as an i.v. medication for the induction of labor in pregnancy with a medical indication. We
are hopeful that our proprietary intranasal dosage form will enhance its properties for use in the underserved population of patients
suffering from binge eating disorder."
TNX-1900* is also in development for the treatment
of chronic migraine and is expected to enter a multi-site Phase 2 potential pivotal clinical trial for the prevention of migraine headache
in chronic migraineurs in the second half of 2022.
"The binge eating disorder trial is expected
to provide a rich source of data to evaluate the potential clinical benefit of TNX-1900 on binge eating disorder, which is often seen
in association with other behavioral conditions such as depression, substance abuse and posttraumatic stress disorder, and is often under-diagnosed
and under-treated," said Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary Oxytocin Research Program, Neuroendocrine
Unit, Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School and principal investigator of the trial.
"While available psychological and pharmacological treatments produce remission from binge eating in some cases, up to 50% of patients
continue to binge, and weight loss in those with obesity is difficult to achieve and sustain. There is accumulating evidence that oxytocin
may reduce food intake by acting on neural pathways involved in reward and impulse control, which have been implicated in binge eating
disorder. We are excited to investigate TNX-1900 as a potential novel therapy to reduce binge eating and excess body weight in individuals
with binge eating disorder."
Dr. Lawson previously led a program of research
suggesting intranasal oxytocin reduces food intake, modulates the neural circuitry driving eating behavior, and enhances impulse control
in men with overweight and obesity.4-7
The planned investigator initiated Phase 2
clinical trial will be a randomized, double-blind, placebo-controlled study of 60 patients with binge eating disorder and obesity. The
8-week study will evaluate the efficacy and safety of TNX-1900 as a treatment for binge eating disorder and determine whether TNX-1900
reduces bingeing frequency and body weight in adults with binge eating disorder and obesity, and underlying mechanisms.
is an investigational new drug and has not been approved for any indication.
(accessed Feb 23, 2022)
JI, et al. (2007) [Published correction appears in Biol Psychiatry. 2012;72(2):164.] Biol Psychiatry. 61(3):348-358.
doi: 10.1016/j.biopsych.2006.03.040.
3Howden LM and Meyer JA.
(2011) Age and sex composition: 2010. US Census Bureau
EA et al. (2015) Oxytocin reduces caloric intake in men. Obesity 23(5):950-6. doi: 10.1002/oby.21069.
5Plessow F. et al. (2018)
Effects of intranasal oxytocin on the blood oxygenation level-dependent signal in food motivation and cognitive control pathways in overweight
and obese men. Neuropsychopharmacology 43(3):638-645. doi: 10.1038/npp.2017.226.
6Kerem L et al. (2020)
Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity. In
J Obes 44(5):980-989. doi: 10.1038/s41366-019-0489-7.
7Plessow F et al. (2021)
Oxytocin administration increases proactive control in men with overweight or obesity: A randomized, double blind, placebo-controlled
crossover study. Obesity 29(1):56-61. doi: 10.1002/oby.23010.
About Binge Eating Disorder
Binge-eating disorder is a psychiatric illness
characterized by frequent episodes of uncontrollable consumption of large amounts of food. It is the most common eating disorder and
often leads to obesity-associated complications and later psychopathology1. Binge eating disorder is characterized by increased
homeostatic appetite and sensitivity to reward (including food reward), which may lead to initiation of binge episodes, and a reduced
ability to control behavioral impulses and formed habits, creating an imbalance in the sensitive interplay between these bottom-up and
top-down processes governing the adaptive regulation of food intake and energy balance2-5.
AE et al. (2012) Prospective association of common eating disorders and adverse outcomes. Pediatrics, 130: e289-95.
doi: 10.1542/peds.2011-3663.
S. & Loxton NJ, (2004) The role of impulsivity in the development of substance use and eating disorders Neurosci Biobehav Rev.
28(3):343-51. doi: 10.1016/j.neubiorev.2004.03.007.
KE et al. (2017) Food-Related Impulsivity in Obesity and Binge Eating Disorder-A Systematic Update of the Evidence. Nutrients 9(11):1170. doi:
D et al. (2019) Meal-Related Acyl and Des-Acyl Ghrelin and Other Appetite-Related Hormones in People with Obesity and Binge Eating. Obesity
27(4):629-635. doi: 10.1002/oby.22431.
K et al. (2013) Food-related impulsivity in obesity and binge eating disorder--a systematic review. Obes Rev. 14(6):477-95. doi:
About TNX-1900 and Tonix's Potentiated
TNX-1900 is based on a proprietary
potentiated formulation of oxytocin and is currently being developed as a candidate for prophylaxis of chronic migraine, the
treatment of insulin resistance1 and related conditions.TNX-1900 is based on Tonix's patented intranasal
potentiated oxytocin formulation. Tonix is also developing a different intranasal formulation, designated TNX-2900, for the
treatment of Prader-Willi syndrome. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. 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 form of oxytocin was marketed in the U.S. by Novartis to
assist in the production of breast milk as Syntocinon ** (oxytocin nasal 40 units/ml), but the product was withdrawn, and the
New Drug Application has been discontinued. TNX-1900 and TNX-2900 are in the pre-Investigational New Drug stage and have not been
approved for any indication.
1Deblon N, et al. (2011)
PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565
*Pitocin is a trademark of Par
Pharmaceutical, Inc.
**Syntocinon is a trademark of
BGP Products Operations GmbH
About Tonix Pharmaceuticals Holding
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, 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 rejection treatment
of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix's infectious disease
pipeline includes next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID.
The pipeline also includes a vaccine in development to prevent smallpox. Tonix's lead vaccine candidate for COVID-19, TNX-18002,
is a live virus vaccine based on Tonix's recombinant pox vaccine (RPV) platform. TNX-35003 (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 SL4 ,