Tonix Pharmaceuticals to Deliver an Oral Presentation and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
22 Maggio 2024 - 2:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, today
announced that the Company will deliver an oral presentation and
present two posters at the American Society of Clinical
Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024
at the Loews Miami Beach Hotel in Miami Beach, Fla.
The oral presentation will detail findings of
studies of Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl) in
fibromyalgia. One poster will describe the Phase 2 proof of concept
study of TNX-102 SL in fibromyalgia-type Long COVID. The second
poster will describe the upcoming investigator-initiated Phase 2
trial of TNX-102 SL in treating acute stress disorder and
preventing posttraumatic stress disorder after motor vehicle
collision, which will be conducted by the University of North
Carolina, the sponsor of the study.
TNX-102 SL is a centrally acting, non-opioid
medication, which is trade named Tonmya™ for the management of
fibromyalgia. As previously announced, the second statistically
significant Phase 3 study of Tonmya, RESILIENT, met its
pre-specified primary endpoint, significantly reducing daily pain
compared to placebo in participants with fibromyalgia (p=0.00005).
Statistically significant and clinically meaningful results
(p=0.001 or better) were also seen in all key secondary endpoints
related to improving sleep quality, reducing fatigue, and improving
overall fibromyalgia symptoms and function.
Tonix plans to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) in the second
half of 2024 for Tonmya for the management of fibromyalgia and has
scheduled a Type B pre-NDA meeting with FDA for the second quarter
of 2024.
Copies of the Company’s presentation and posters
will be available under the Scientific Presentations tab of the
Tonix website at www.tonixpharma.com following the conference.
Additional meeting information can be found on the ASCP website
here.
Oral Presentation Details
Presenter: |
Seth Lederman, M.D., Chief Executive Officer |
Title: |
Effects of Bedtime TNX-102 SL
(Sublingual Cyclobenzaprine (CBP) HCl) on Mood and Anxiety Symptoms
in Fibromyalgia: Results of the Phase 3 RESILIENT Trial |
Date/Time: |
May 29, 2024, 3:00 p.m. ET |
Poster Presentation Details
Presenter: |
Herbert Harris, M.D., Ph.D., Executive Vice President,
Translational Medicine |
Title: |
Effect of Bedtime Sublingual
Cyclobenzaprine (TNX-102 SL) on Pain, Sleep, Fatigue and Cognition
in Fibromyalgia-Type Long COVID: Results of a Double-Blind
Randomized Proof-of-Concept Phase 2 Study |
Date/Time: |
May 30, 2024, 12:30 p.m. ET |
Presenter: |
David Hsu, Ph.D., Senior
Scientist |
Title: |
Optimizing Acute Stress Reaction
(ASR) Interventions with TNX-102 SL (Sublingual Cyclobenzaprine
HCl) – The OASIS Trial: Sustaining Civilian Performance Post-Trauma
by Reduction of ASR and Prevention of ASD/PTSD |
Date/Time: |
May 30, 2024, 12:30 p.m. ET |
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a fully-integrated 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 second half of 2024 for
Tonmya1, a product candidate for which two statistically
significant Phase 3 studies have been completed for the management
of fibromyalgia. TNX-102 SL is also being developed to treat acute
stress reaction as well as fibromyalgia-type Long COVID. Tonix’s
CNS portfolio includes TNX-1300 (cocaine esterase), a biologic
designed to treat cocaine intoxication that has Breakthrough
Therapy designation. Tonix’s immunology development portfolio
consists of biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. Tonix also has product candidates
in development in the areas of rare disease and infectious disease.
Tonix Medicines, our commercial subsidiary, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or
without aura in adults.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. All other marks are property of
their respective owners.
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 the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; risks related to the
timing and progress of clinical development of our product
candidates; 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, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Katie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
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