Tonix Pharmaceuticals Presented New Data on Tonmya™ Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual Meeting
June 03 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 new data from the Phase 3 RESILIENT trial of Tonmya
(TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the
management of fibromyalgia in an oral presentation at the American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May
29, 2024 in Miami Beach, Fla. A copy of the presentation is
available under the Scientific Presentations tab of the Tonix
website at www.tonixpharma.com.
In the oral presentation titled, “Effects of
Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) on Mood and
Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT
Trial,” Seth Lederman, MD, Chief Executive Officer, presented new
data suggesting activity for improvement in depressive symptoms
with Tonmya.
Depression was frequent among patients enrolled
in the RESILIENT trial: ~47% reported experiencing depression
within the past 6 months upon fibromyalgia diagnosis and ~25% of
the intent-to-treat (ITT) population had experienced a lifetime
major depressive episode (MDE). The effect of Tonmya on depressive
symptoms was studied using the Beck Depression Inventory-II
(BDI-II). Patients started with a baseline mean (standard
deviation) for placebo of 10.0 (6.72) and Tonmya of 9.6 (6.32). The
BDI-II score separated at Week 2 with a nominal p-value of
<0.01. By Week 14, the total BDI-II score in the TNX-102 SL
group improved over placebo with a nominal p-value of 0.005 and an
effect size of 0.27.
Dr. Lederman said, “Although pain is the
prototypic symptom in fibromyalgia and the validated FDA endpoint
for the approval of a new drug, depression severity is also a
prominent factor in the quality of life for fibromyalgia sufferers.
In one study, depressive symptoms had a higher correlation with
impaired quality of life than any other symptom, including pain
frequency and intensity.2 The improvement in depression observed in
the Phase 3 RESILIENT was particularly striking since the mean
entry score of 10 reflects mild depression. Others have struggled
to show benefits of traditional antidepressants in mild depression
and consequently many antidepressants have been studied in moderate
or severely depressed patients and the benefits of such drugs for
patients with mild depression have been inferred.”
Dr. Lederman continued, “In addition to the
BDI-II score, in post hoc analyses several individual items on the
Fibromyalgia Impact Questionnaire-Revised (FIQR) also improved in
the Tonmya-treated group, including : depression (p < 0.001),
anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p =
0.001) and energy (p < 0.001), for which these p-values were not
corrected for multiplicity. Together these findings indicate that
Tonmya has broad-spectrum activity against fibromyalgia symptoms
and may improve fibromyalgia at the syndromal level.”
In the RESILIENT trial, as previously reported,
Tonmya improved overall daily pain (p=0.00005), the pre-specified
primary endpoint, making it the second Phase 3 study of Tonmya in
the management of fibromyalgia to reach statistical significance on
the pre-specified primary endpoint. Tonmya also demonstrated
statistically significant and clinically meaningful results 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.”
In the RESILIENT trial, there were no new safety
signals, low rates of systemic adverse events, and a favorable
tolerability profile.
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 and has scheduled a
Type B pre-NDA meeting with FDA for the second quarter of 2024.
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.
2Offenbaecher M, et al. Pain is not the major
determinant of quality of life in fibromyalgia. Rheumatology
International 2021; 41:1995–2006
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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