Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, held a key opinion leader (KOL)
webinar to discuss the positive Phase 3 data of Tonmya™ (also known
as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the
management of fibromyalgia, and the path to file for FDA approval
in the second half of 2024. The webinar was held on January 31,
2024 and hosted by Alliance Global Partners (A.G.P.).
The webinar featured two thought leaders in the
field of fibromyalgia: Daniel Clauw, M.D., Professor of
Anesthesiology, Medicine and Psychiatry, Director Chronic Pain
& Fatigue Research Center, University of Michigan, and Lesley
Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience,
University of Cincinnati College of Medicine.
A replay of the webinar is available here.
Tonmya™ is a centrally acting, non-opioid,
non-addictive, bedtime medication. As previously announced, Tonix’s
second positive Phase 3 study, RESILIENT, met its pre-specified
primary endpoint, significantly reducing daily pain compared to
placebo (p=0.00005) in participants with fibromyalgia.
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.
“These data offer new hope for patients with
fibromyalgia,” said Dr. Arnold. “Many of my patients have required
combination treatments to combat their multiple
fibromyalgia-related symptoms. We haven’t seen a medication that
can treat fatigue, sleep, and pain all together. Having a compound
like Tonmya™ that may address all three is very exciting.”
“The fact that cyclobenzaprine was beneficial in
many other key symptom domains, including sleep quality, is
important to fibromyalgia patients,” said Dr. Clauw. “We’re really
beginning to understand how crucial sleep is in alleviating and
potentially preventing fibromyalgia symptoms.”
Dr. Arnold stated that most patients are open to
new treatment options, citing lack of efficacy in some cases,
tolerability issues and unwanted side effects associated with the
currently approved fibromyalgia treatments. “Since patients
typically need to be treated for prolonged periods of time, it is
important to develop a therapeutic which is well-tolerated.”
“We believe that these positive results show
that fibromyalgia can be successfully treated by Tonmya™ and may
provide the opportunity for Tonix to have the first FDA-approved
drug for fibromyalgia in more than a decade,” said Seth Lederman,
M.D., President and Chief Executive Officer of Tonix
Pharmaceuticals. “We are now an important step closer to bringing a
new, first-line treatment to fibromyalgia patients that offers
broad symptom relief and favorable tolerability for chronic use and
adherence.”
About the Phase 3 RESILIENT
StudyThe RESILIENT study was a double-blind, randomized,
placebo-controlled trial designed to evaluate the efficacy and
safety of Tonmya™ (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 FibromyalgiaFibromyalgia
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 Tonmya™ (also known as TNX-102
SL)Tonmya 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. Tonmya 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, Tonmya
is in development as a daily bedtime treatment for fibromyalgia.
TNX-102 SL is also in development 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 Tonmya
composition. These patents are expected to provide Tonmya, 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 Tonmya, 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 Tonmya for the
management of fibromyalgia in the second half of 2024. TNX-102 SL
is being developed to reduce the severity of acute stress reaction
and the frequency of acute stress disorder and posttraumatic stress
disorder. This trial is being sponsored by the University of North
Carolina and received funding support from the U.S. Department of
Defense. 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 and received
funding from the National Institute on Drug Abuse (NIDA). 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
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 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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