Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals Presented New Data
on Tonmya Suggesting Activity for Improvement in Fibromyalgia-Associated Depression Severity in an Oral Presentation at ASCP Annual
Tonmya treatment was associated with improvement
in depressive symptoms as measured by the Beck Depression Inventory-II
In addition, post-hoc analyses showed improvement
in depression, anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised
New Drug Application (NDA) submission to
the FDA on track for the second half of 2024
CHATHAM, N.J., June 3, 2024 - 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
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.
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.
Tonix Pharmaceuticals