Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, announced
today an exclusive agreement to in-license a triple reuptake
inhibitor (TRI), TNX-1600 (formerly D-578), to treat posttraumatic
stress disorder (PTSD) and potentially other central nervous system
(CNS) disorders. The compound was developed and pharmacologically
characterized by Aloke Dutta, Ph.D., professor of Pharmaceutical
Sciences at Wayne State University, with funding from a National
Institutes of Health grant (grant number MH084888), and the patents
covering the compounds were licensed to TRImaran Pharma, Inc.
(TRImaran). The transaction announced today is a license agreement
with Wayne State and an asset acquisition with TRImaran.
“We are excited to expand our pipeline and are
looking forward to developing TNX-1600 as a potential treatment for
PTSD,” said Seth Lederman, M.D., Tonix's President and Chief
Executive Officer. “We plan to utilize our clinical experience in
PTSD to evaluate the therapeutic benefit of TNX-1600. PTSD is a
heterogeneous condition, so we believe different PTSD patients may
respond to different medicines. In some cases, more than one drug
will be required for effective treatment. TNX-1600 is our third
drug candidate in development for PTSD. Our most advanced candidate
is TNX-102 SL, which is in Phase 3 development. We are also
developing TNX-601 which is entering a Phase 1 trial imminently.
TNX-1600 is in the pre-IND phase of development with encouraging
data from animal models of PTSD.”
Frank Bymaster, Chief Scientific Officer and
co-founder of TRImaran Pharma Inc. said, “TNX-1600 is a novel TRI
that inhibits simultaneously the reuptake of three key
neurotransmitters: serotonin, norepinephrine and dopamine. Each of
these three neurotransmitters plays a key modulatory role in many
CNS processes. Inhibiting reuptake of all three may provide an
effective treatment for PTSD.”
According to Dr. Aloke Dutta, “We have developed an
innovative triple reuptake inhibitor, D-578, based on a unique
pyran molecular scaffold to address the current therapeutic needs
for PTSD and other neurological disorders. Based on our preliminary
data, we expect a pharmacological synergy from their potent
modulatory effect on the level of monoamine neurotransmitters in
the brain which should facilitate effective treatment of these
disorders.”
Under the terms of the agreement, Tonix has been
granted an exclusive license from Wayne State University for
technology and patents related to TNX-1600 and other pyran-based
compounds. Another member of the class, D-473, has also shown
effects in a rodent model of depression2,3.
1Bymaster, FP, Lisieski M, Harutyunyan, A, Das, D,
Liberzon, I, Hsu,T, Reith, MEA, Perrine, SA, Dutta, AK, A Novel
Orally Active Triple Reuptake Inhibitor for the Treatment of
Post-traumatic Stress Disorder (PTSD): D-578 Attenuates Abnormal
Fear Behavior in a Rodent Model of Traumatic Stress. 2Soumava
Santra, S, Gogoi, S, Gopishetty, B, Antonio, T,
Zhen, J, Reith, MEA and Dutta, AK. Structural
Exploration of (3S,6S)-6-Benzhydryl-N-
benzyltetrahydro-2H-pyran-3-amine Analogues: Identification of
Potent Triple Monoamine Reuptake Inhibitors as Potential
Antidepressants. ChemMedChem, 20123Dutta, AK, Santra, S, Sharma, H,
Voshavar, C Xu,L, Mabrouk, O, Antonio, T and Reith, MEA.
Pharmacological and behavioral characterization of an orally active
triple reuptake inhibitor D-473: Effects of drug on extracellular
levels of dopamine, serotonin and norepinephrine. Plos
One, 2014, 9, e11342 0.
About TRImaranTRImaran Pharma,
Inc. was co-founded by Frank Bymaster (CSO), Dr. Timothy Hsu (CMO)
and Walter Piskorski (CEO), along with Aloke Dutta, Ph.D.
(inventor/scientific advisor), to apply their psychiatric drug
development expertise, particularly for TRIs. TRImaran
originally in-licensed the exclusive rights to these compounds from
Wayne State University and, as part of this transaction,
transferred those rights to Tonix.
About Wayne State
UniversityWayne State University is one of the nation’s
pre-eminent public research universities in an urban setting.
Through its multidisciplinary approach to research and education,
and its ongoing collaboration with government, industry and other
institutions, the university seeks to enhance economic growth and
improve the quality of life in the city of Detroit, state of
Michigan and throughout the world. For more information about
research at Wayne State University, visit
http://www.research.wayne.edu.
About Triple Reuptake Inhibitors
(TRIs)TRIs inhibit simultaneously the reuptake of three
key neurotransmitters: serotonin, norepinephrine and dopamine.
Single selective serotonin reuptake inhibitors are known as SSRIs
and have been successful in a number of psychiatric conditions and
include the drugs Prozac® (fluoxetine), Paxil® (paroxetine),
Zoloft® (sertraline), and Celexa® (escitalopram). Double serotonin
and norepinephrine inhibitors are known as SNRIs and include
successful drugs like Effexor® (venlafaxine) and Cymbalta®
(duloxetine). A number of TRIs are in development, but none have
been approved by the FDA for marketing.
About 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, to be
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. TNX-601 (tianeptine oxalate) is in the pre-IND
application stage, also for the treatment of PTSD but by a
different mechanism from TNX-102 SL and designed for daytime
dosing. 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 U.S.
Food and Drug Administration (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.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking StatementsCertain
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 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.
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)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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