Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced the
presentation of additional efficacy data from RESILIENT, the second
positive Phase 3 study evaluating Tonmya (also known as TNX-102 SL,
cyclobenzaprine HCl sublingual tablets) for the management of
fibromyalgia, at the 6th International Congress on Controversies in
Fibromyalgia in Brussels, Belgium, March 7-8, 2024.
In presenting more detailed data from the
RESILIENT study, Seth Lederman, M.D., President and Chief Executive
Officer of Tonix Pharmaceuticals, said, “We previously reported
statistically significant and clinically meaningful results in all
six key secondary endpoints related to improving sleep quality,
reducing fatigue, and improving overall fibromyalgia symptoms and
function. We now report that the effect sizes of the five
continuous key secondary outcomes measures ranged from 0.3 to 0.5.
The results also showed that Tonmya treatment resulted in an
improvement in cognitive dysfunction, or ‘brain fog’, measured by
the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
memory item. The FIQ-R cognitive item showed nominal improvement in
Tonmya-treated patients vs placebo-treated patients with a p=0.001
and effect size of 0.31. Together, we believe the activity of
Tonmya on pain, sleep quality, fatigue and brain fog are indicative
of broad-spectrum activity of Tonmya and suggest that Tonmya treats
fibromyalgia at a syndromal level.”
As previously announced, RESILIENT met its
pre-specified primary endpoint, significantly reducing daily pain
compared to placebo (p=0.00005) in participants with fibromyalgia.
RELIEF, the first Phase 3 trial of Tonmya 5.6 mg in fibromyalgia,
was completed in December 2020. It also met its pre-specified
primary endpoint of daily pain reduction compared to placebo
(p=0.010). Tonix plans to submit a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) in the second half of
2024 and has scheduled a pre-NDA meeting with FDA in the second
quarter of 2024.
Tonmya was not associated with increases in
systolic or diastolic blood pressure or body weight, nor were there
any reported sexual side effects in the RESILIENT trial. In
addition, when systematically investigated using the Changes in
Sexual Functioning Questionnaire short form (CSFQ-14), women who
received study drug had a higher CSFQ-14 total score relative to
those who received placebo, which is consistent with improved
sexual function.
Dr. Gregory Sullivan, Chief Medical Officer of
Tonix Pharmaceuticals said, “These are important tolerability
factors for fibromyalgia patients on long-term treatment with the
three FDA-approved drugs, since weight gain and fatigue are
associated with gabapentinoids, and negative sexual side effects,
increased blood pressure and insomnia are associated with
SNRIs.”
Dr. Lederman added, “We believe that the data
from our two positive Phase 3 studies, with clinically meaningful
separation from placebo on pain, sleep disturbance, and fatigue,
supports the conclusion that fibromyalgia may be successfully
treated with Tonmya 5.6 mg, and may provide the opportunity for
Tonix to launch the first FDA-approved drug for fibromyalgia in
more than a decade. We are excited to bring forward a new
first-line treatment to fibromyalgia patients that offers broad
symptom relief with favorable tolerability attributes for chronic
use and adherence, which provides hope for the 6-12 million
affected adults in the U.S.”
Dr. Sullivan added, “We believe that these
broad-spectrum efficacy results will be important to fibromyalgia
patients who struggle not only with pain, but also multiple other
symptoms. We also believe the favorable tolerability and side
effect profiles will be important to patients and doctors managing
this debilitating condition on a long-term basis.”
About the Phase 3 RESILIENT Study
The RESILIENT study is a double-blind,
randomized, placebo-controlled trial designed to evaluate the
efficacy and safety of Tonmya (cyclobenzaprine HCl sublingual
tablets) in the management of fibromyalgia. The two-arm trial
randomized 457 participants in the U.S. across 33 sites. The first
two weeks of treatment consist of a run-in period in which
participants start on Tonmya 2.8 mg (1 tablet) or placebo.
Thereafter, all participants increase their dose to Tonmya 5.6 mg
(2 x 2.8 mg tablets) or two placebo tablets for the remaining 12
weeks. The primary endpoint is the daily diary pain severity score
change (Tonmya 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.
The results showed that Tonmya treatment resulted in an improvement
in cognitive dysfunction or ‘brain fog’ measured by the change in
the FIQ-R memory item. The FIQ-R cognition item showed improvement
in Tonmya treated patients vs placebo treated patients (LS mean
(SE) difference of −0.8 (0.23); nominal p=0.001; effect size 0.31,
no correction for multiple comparisons, mixed model repeated
measures analysis). The Cohen’s d effect sizes (ESs) of the five
continuous key secondary outcomes measures were: Fibromyalgia
Impact Questionnaire-Revised (FIQ-R) – Symptoms domain ES = 0.44,
FIQ-R-Function ES =0.30, PROMIS sleep disturbance ES =0.50, PROMIS
Fatigue ES = 0.37 and Daily Sleep quality rating ES = 0.32. The
most common adverse events were local administration site reactions
that were transient and self-limited.
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 Tonmya* (also known as TNX-102
SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. The tablet is a patented
sublingual formulation of cyclobenzaprine hydrochloride developed
for the management of fibromyalgia. In December 2023, the company
announced highly statistically significant and clinically
meaningful topline results in RESILIENT, a second positive Phase 3
clinical trial of Tonmya for the management of fibromyalgia. In the
study, Tonmya 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 were also seen in all key secondary endpoints
related to improving sleep quality, reducing fatigue and improving
overall fibromyalgia symptoms and function. RELIEF, the first
positive Phase 3 trial of Tonmya in fibromyalgia, was completed in
December 2020. It met its pre-specified primary endpoint of daily
pain reduction compared to placebo (p=0.010) and showed activity in
key secondary endpoints.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration as the tradename for TNX-102 SL for
the management of fibromyalgia. Tonmya has not been approved for
any indication.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a 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 Tonmya, a product candidate for
which two positive 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 with 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.
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.com(919)
360-3039
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