Tonix Pharmaceuticals Presented Poster of Tonmya™ for the Management of Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2024
June 17 2024 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates,
presented data from a poster presentation at the Annual European
Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the
Messe Wien Congress Center in Vienna, Austria. A copy of the
Company’s poster presentation is available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com.
In the poster presentation titled, “Targeting
Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL
(Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in
RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial”,
Tonyma met the pre-specified primary endpoint in the Phase 3
RESILIENT trial, significantly reducing daily pain compared to
placebo (p-value=0.00005) in participants with fibromyalgia while
also demonstrating broad syndromal improvement. Tonmya demonstrated
statistically significant improvement in all six pre-specified key
secondary endpoints including those related to improving sleep
quality, reducing fatigue, and improving patient global ratings and
overall fibromyalgia symptoms and function. Tonmya was well
tolerated with an adverse event (AE) profile comparable to prior
studies and no new safety signals observed.
In pre-specified exploratory analyses, Tonmya
treatment also improved depressive symptoms measured by the Beck
Depression Inventory and improved female sexual function by the
Changes in Sexual Function Questionnaire in the RESILIENT
trial.
“People suffering with fibromyalgia tend to
struggle with daily activities, have impaired quality of life and
are frequently disabled”, said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “We believe the activity of
Tonmya on pain, sleep quality, fatigue cognitive dysfunction, and
depression are indicative of the broad-spectrum activity of Tonmya,
suggesting Tonmya treats fibromyalgia at a syndromal level. We are
excited by the prospect of offering this patient population its
potential first new therapy option in more than a decade.”
Tonix remains on track to submit an NDA to the
U.S. Food and Drug Administration (FDA) in the second half of 2024
for Tonmya for the management of fibromyalgia.
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 FDA Breakthrough
Therapy designation and is in Phase 2 development supported by a
grant from the National institute of Drug Abuse. 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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