Tonix Pharmaceuticals Announces Publication of Paper on Triple Reuptake Inhibitor TNX-1600 (formerly D-578) in the European J...
September 16 2019 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the publication of a paper entitled “D-578, an orally
active triple monoamine reuptake inhibitor, displays antidepressant
and anti-PTSD effects in rats” in the European Journal of
Pharmacology. The paper summarizes the behavioral pharmacological
characterization of a novel triple reuptake inhibitor (TRI),
TNX-1600, formerly known as D-578, which exhibits nanomolar potency
at all three monoamine transporters (NET > SERT ≈ DAT) and
exhibited little to no affinity for other off-target central
nervous system (CNS) receptors. TNX-1600 was found to have greater
efficacy in normalizing traumatic stress-induced
extinction-retention learning in an animal model for posttraumatic
stress disorder (PTSD) compared to paroxetine, a selective
serotonin reuptake inhibitor (SSRI), which is approved by the U.S.
Food and Drug Administration (FDA) to treat PTSD and other
psychiatric conditions. These findings suggest TNX-1600 may reduce
maladaptive retention of fearful memories via attenuation of the
extinction learning and extinction retention deficits induced by
traumatic stress, supporting further testing of this agent for the
pharmacotherapy of PTSD. Additionally, TNX-1600 showed a robust
effect in an animal model associated with antidepressant activity
without affecting locomotor activity.
In August 2019, Tonix announced an exclusive license agreement
with Wayne State University and an asset acquisition with TRImaran
Pharma, Inc. (TRImaran) to in-license TNX-1600 to treat PTSD and
potentially other CNS disorders. Under the terms of the agreement,
Tonix was granted an exclusive license from Wayne State University
for technology and patents related to TNX-1600 and other
pyran-based compounds.
Tonix’s President and Chief Executive Officer, Seth Lederman,
M.D. said, “We are pleased to see the paper on TNX-1600 published
in this peer-reviewed journal, and we believe that the findings
support the development of this novel TRI as a potential treatment
for PTSD.”
Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering and developing small molecules and
biologics to treat psychiatric, pain and addiction conditions, to
improve biodefense through potential medical counter-measures and
to prevent and treat organ transplant rejection. Tonix’s lead
program is for the development of Tonmya* (TNX-102 SL), which is in
Phase 3 development as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for fibromyalgia,
agitation in Alzheimer’s disease and alcohol use disorder, is being
developed under separate Investigational New Drug applications
(INDs) to support potential pivotal efficacy studies. The
fibromyalgia program is in Phase 3 development, the agitation in
Alzheimer’s program is Phase 2 ready and the alcohol use disorder
program is in the pre-IND application stage. TNX-1300**
(double-mutant cocaine esterase) is being developed under an IND
and is in Phase 2 development for the treatment of cocaine
intoxication. Tonix has two other programs in the pre-IND
application stage of development for PTSD, but with different
mechanisms than TNX-102 SL and designed for daytime dosing: TNX-601
(tianeptine oxalate) and TNX-1600***, a triple reuptake inhibitor.
TNX-601 is also in development for a potential indication -
neurocognitive dysfunction associated with corticosteroid use. Data
is expected in the second half of 2019 for a Phase 1 clinical
formulation selection pharmacokinetic study of TNX-601 that is
being conducted outside of the U.S. TNX-801 (live virus vaccine for
percutaneous (scarification) administration) is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
Finally, TNX-1500 is being developed to prevent and treat organ
transplant rejection, as well as to treat autoimmune conditions,
and is in the pre-IND application stage.
*Tonmya has been conditionally accepted by the
FDA as the proposed trade name for TNX-102 SL for the treatment of
PTSD. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
**TNX-1300 (T172R/G173Q double-mutant cocaine
esterase 200 mg, i.v. solution) is an investigational new biologic
and has not been approved for any indication.
***TNX-1600
((2S,4R,5R)-5-(((2-aminobenzo[d]thiazol-6-yl)methyl)amino)-2-(bis(4-fluorophenyl)methyl)tetrahydro-2H-pyran-4-ol)
is an inhibitor of reuptake of three monoamine neurotransmitters
(serotonin, norepinephrine and dopamine), or a “triple reuptake”
inhibitor.
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
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and periodic reports on
Form 10-Q filed with the SEC on or after the date thereof. Tonix
does not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo
(investors)Westwickepeter.vozzo@westwicke.com (443) 213-0505
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