Tonix Pharmaceuticals Presented Results from Pharmacokinetic Analyses of TNX-102 SL in a Poster Presentation at the American ...
May 30 2019 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company) a clinical-stage biopharmaceutical company focused on
developing small molecules and biologics to treat psychiatric, pain
and addiction conditions as well as to improve biodefense,
presented a poster at the American Society of Clinical
Psychopharmacology (ASCP) 2019 Annual Meeting held May 28-31, 2019,
in Scottsdale, Ariz. The poster, titled “Steady-State
Pharmacokinetic Properties of a Sublingual Formulation of
Cyclobenzaprine (CBP) HCl (TNX-102 SL*): Comparison to Simulations
of Oral Immediate Release CBP” includes pharmacokinetic, or PK,
analyses of TNX-102 SL. The poster can be found on the Scientific
Presentations page of Tonix’s website.
The poster presentation reports PK results of
TNX-102 SL, a sublingual form of cyclobenzaprine (CBP), studied in
a comparative PK, open-label, randomized, parallel, two-arm,
multiple-dose bridging study, with the reference listed drug AMRIX®
(cyclobenzaprine HCl extended release capsules). TNX-102 SL is
being developed as a potential treatment for posttraumatic stress
disorder (PTSD), fibromyalgia (FM) and agitation in Alzheimer’s
disease (AAD), which are central nervous system (CNS) conditions in
which sleep disturbances are believed to play essential roles in
the illness expression.
Gregory M. Sullivan, M.D., Chief Medical Officer,
Tonix Pharmaceuticals Holdings Corp., commented, “We believe this
study serves to bridge TNX-102 SL to the safety findings and
relevant labeling information of AMRIX, qualifying it for the
505(b)(2) regulatory approval pathway, which is intended to
streamline the U.S. Food and Drug Administration (FDA) approval of
pharmaceutical products that incorporate already-approved
pharmacological agents.”
Dr. Sullivan added, “Designing a drug begins with
the active ingredient, but formulation is key to improving
characteristics such as how much of the administered drug gets to
the target organ and how quickly it gets there. For TNX-102 SL the
target organ is the brain, and CBP is known to efficiently pass
from the blood stream to the brain. We believe that data from this
PK study confirms that TNX-102 SL as a sublingual tablet delivers
CBP dynamically into the blood stream with reduced formation of
nCBP, which are properties that we consider optimized for a sleep
quality drug. We believe these data support the use of TNX-102 SL
as a potential chronic bedtime treatment for PTSD, FM and AAD.”
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical company
focused on discovering and developing pharmaceutical products to
treat psychiatric, pain and addiction conditions, and biological
products to improve biodefense through potential medical
counter-measures. 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. TNX-102 SL for the treatment of PTSD has U.S.
Food and Drug Administration (FDA) Breakthrough Therapy
designation. Tonix is also developing TNX-102 SL as a bedtime
treatment for fibromyalgia and agitation in Alzheimer’s disease
under separate Investigational New Drug applications (INDs) to
support potential pivotal efficacy studies. The fibromyalgia
program is in Phase 3 development and the agitation in Alzheimer’s
program is Phase 2 ready. The agitation in Alzheimer’s disease IND
has been designated a Fast Track development program by the FDA.
TNX-1300*** (T172R/G173Q double-mutant cocaine esterase 200 mg,
i.v. solution) is being developed under an IND and is in Phase 2
development for the treatment of cocaine intoxication. TNX-1300
(formerly known as RBP-8000) is a recombinant protein enzyme
produced through rDNA technology in a non-disease-producing strain
of E. coli bacteria. TNX-1300 for cocaine intoxication has FDA
Breakthrough Therapy designation. 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. A Phase 1 clinical formulation selection
pharmacokinetic study of TNX-601 will be conducted outside of the
U.S. in 2019. 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.
*TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) is an investigational new drug and has not been approved
for any indication.
**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-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 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
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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