Tonix Pharmaceuticals Announces KOL Webinar to Discuss Positive Phase 3 Fibromyalgia Data, Sponsored by A.G.P.
25 Enero 2024 - 6:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced a key opinion
leader (KOL) webinar to discuss the positive Phase 3 data of
TNX-102 SL for the management of fibromyalgia. The webinar will
feature two esteemed thought leaders in the field of fibromyalgia
and will be hosted by Alliance Global Partners.
KOL Webinar Details |
Title: |
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KOL Discussion
on Positive Phase 3 Data and Advantages Over Current Therapies |
Date: |
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Wednesday, January 31, 2024, at 1:00 p.m. ET. |
Participants: |
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Daniel Clauw, M.D., Professor of Anesthesiology, Medicine and
Psychiatry, Director Chronic Pain & Fatigue Research
Center |
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Lesley Arnold, M.D., Professor of Psychiatry and Behavioral
Neuroscience, University of Cincinnati College of Medicine |
|
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Seth Lederman, M.D., President and CEO of Tonix
Pharmaceuticals |
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Gregory Sullivan, M.D., Chief Medical Officer of Tonix
Pharmaceuticals |
Webcast link: |
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Click here to register/join webinar |
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A replay of the webinar will be available under
the IR Events tab of the Tonix website at
www.tonixpharma.com following the event.
About the Phase 3 RESILIENT
Study
The RESILIENT study was a double-blind,
randomized, placebo-controlled trial designed to evaluate the
efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) for the management of fibromyalgia. The two-arm trial
randomized 457 participants in the U.S. across 33 sites. The first
two weeks of treatment consisted of a run-in period in which
participants started on TNX-102 SL 2.8 mg (1 tablet) or placebo.
Thereafter, all participants increased their dose to TNX-102 SL 5.6
mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12
weeks. The study met the pre-specified primary endpoint of daily
diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo)
from baseline to Week 14 (using the weekly averages of the daily
numerical rating scale scores), analyzed by mixed model repeated
measures with multiple imputation (p=0.00005).
For more information, see ClinicalTrials.gov
Identifier: NCT05273749.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is
understood to result from amplified sensory and pain signaling
within the central nervous system. Fibromyalgia afflicts an
estimated 6 million to 12 million adults in the U.S., the majority
of whom are women. Symptoms of fibromyalgia include chronic
widespread pain, nonrestorative sleep, fatigue, and morning
stiffness. Other associated symptoms include cognitive dysfunction
and mood disturbances, including anxiety and depression.
Individuals suffering from fibromyalgia struggle with their daily
activities, have impaired quality of life, and frequently are
disabled. Physicians and patients report common dissatisfaction
with currently marketed products.
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride which is designed for
daily administration at bedtime with a proposed mechanism of
improving sleep quality in fibromyalgia. TNX-102 SL provides rapid
transmucosal absorption and reduced production of a long half-life
active metabolite, norcyclobenzaprine, due to bypass of first-pass
hepatic metabolism. As a multifunctional agent with potent binding
and antagonist activities at the 5-HT2A-serotonergic,
α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic
receptors, TNX-102 SL is in development as a daily bedtime
treatment for fibromyalgia, fibromyalgia-type Long COVID (formally
known as post-acute sequelae of COVID-19 [PASC]), alcohol use
disorder, and agitation in Alzheimer’s disease. The United States
Patent and Trademark Office (USPTO) issued United States Patent No.
9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No.
10117936 in November 2018, Patent No. 10,357,465 in July 2019, and
Patent No. 10736859 in August 2020. The Protectic™ protective
eutectic and Angstro-Technology™ formulation claimed in the patent
are important elements of Tonix’s proprietary TNX-102 SL
composition. These patents are expected to provide TNX-102 SL, upon
NDA approval, with U.S. market exclusivity until 2034/2035. In
addition, Tonix has pending but not issued U.S. patent applications
directed to the transmucosal absorption of CBP-HCl, with U.S.
market exclusivity expected until 2033, for treating depressive
symptoms in fibromyalgia, with U.S. market exclusivity expected
until 2032, and for treating pain in fibromyalgia with U.S. market
exclusivity expected until 2041.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix’s
development portfolio is focused on central nervous system
disorders. Tonix’s priority is to submit a New Drug Application
(NDA) to the FDA for TNX-102 SL (cyclobenzaprine HCl sublingual
tablet), which has completed two positive Phase 3 studies for the
management of fibromyalgia. Tonix intends to meet with the FDA in
the first half of 2024 and submit an NDA for the approval of
TNX-102 SL for the management of fibromyalgia in the second half of
2024. TNX-102 SL is also being developed to treat fibromyalgia-type
Long COVID, a chronic post-acute COVID-19 condition, and topline
results from a proof-of-concept study were reported in the third
quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed
to treat cocaine intoxication and has been granted Breakthrough
Therapy designation by the FDA. A Phase 2 study of TNX-1300 is
expected to be initiated in the first quarter of 2024. Tonix’s rare
disease development portfolio includes TNX-2900 (intranasal
potentiated oxytocin) for the treatment of Prader-Willi syndrome
(PWS). TNX-2900 has been granted Orphan Drug designation by the FDA
and an investigational new drug (IND) application has been cleared
to support a Phase 2 study in PWS patients. Tonix’s immunology
development portfolio includes 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. A Phase 1
study of TNX-1500 was initiated in the third quarter of 2023.
Tonix’s infectious disease pipeline includes TNX-801, a vaccine in
development to prevent smallpox and mpox. TNX-801 also serves as
the live virus vaccine platform or recombinant pox vaccine platform
for other infectious diseases, including TNX-1800, in development
as a vaccine to protect against COVID-19. During the fourth quarter
of 2023, TNX-1800 was selected by the U.S. National Institutes of
Health (NIH), National Institute of Allergy and Infectious Diseases
(NIAID) Project NextGen for inclusion in Phase 1 clinical trials.
The infectious disease development portfolio also includes TNX-3900
and TNX-4000, which are classes of broad-spectrum small molecule
oral antivirals. Tonix Medicines, our commercial subsidiary,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg under a transition
services agreement with Upsher-Smith Laboratories, LLC from whom
the products were acquired on June 30, 2023. Zembrace SymTouch and
Tosymra are each indicated 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.
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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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