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 publication
of a research paper in the Journal Psychiatry Research. The article
titled, “A Phase 3, Randomized, Placebo-Controlled, Trial to
Evaluate the Efficacy and Safety of Bedtime Sublingual
Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic
Stress Disorder,” by Parmenter, et al. found that bedtime TNX-102
SL* treatment is well-tolerated and showed nominal improvement in
PTSD severity and sleep quality measures in the first four weeks in
military-related posttraumatic stress disorder (PTSD).1 The Company
believes these findings suggest a potential role for short-term
bedtime TNX-102 SL treatment in the immediate aftermath of
traumatic events.
The data support the U.S. Department of Defense
(DoD)-funded Phase 2 investigator-initiated OASIS trial to evaluate
bedtime TNX-102 SL2 in reducing the severity of acute stress
reaction (ASR) and the frequency of acute stress disorder (ASD) and
PTSD. The IND supporting the OASIS trial was recently cleared,3 and
the trial is expected to begin enrolling in the second quarter. The
trial is sponsored by The University of North Carolina Institute
for Trauma Recovery and supported by a $3 million grant from DoD.
In the OASIS study, 14 days of bedtime TNX-102 SL 5.6 mg will be
tested in the immediate aftermath of motor vehicle collision.
The study will test the potential for TNX-102 SL treatment
initiated within 24 hours of index trauma to target trauma-related
sleep disturbance and other ASR symptoms to facilitate recovery
from ASR and to prevent PTSD.
“There is an urgent need for interventions to
reduce rates of ASD and PTSD in the immediate aftermath of
trauma,”4 said Seth Lederman, M.D., Chief Executive Officer of
Tonix Pharmaceuticals. “We believe the results in the published
paper suggest that bedtime TNX-102 SL has short-term activity on
improving PTSD symptom severity and sleep quality in
military-related PTSD. Poor sleep after trauma is a risk factor for
progressing from ASD to PTSD. Therefore, poor sleep is not only a
symptom of ASR, ASD and PTSD, but also a potential target of
therapy.”
Dr. Gregory Sullivan, Chief Medical Officer of
Tonix said, “Sleep disturbances are known to play a critical role
in the development and maintenance of PTSD. The upcoming OASIS
trial will test a 14-day short-course of bedtime TNX-102 SL therapy
beginning within 24 hours of index trauma for effects on ASR
symptoms and incidence of PTSD development. We are excited to test
bedtime TNX-102 SL in the immediate aftermath of trauma to learn
whether drug intervention reorients the trajectory of posttraumatic
pathology from acute trauma to early recovery in the first few
weeks.”
About TNX-102 SL (also known as Tonmya™
for the management of fibromyalgia)
PTSD: The Phase 3 HONOR study
described in the published article was performed in
military-related PTSD with the primary endpoint of improvement from
baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
total score at Week 12 comparing TNX-102 SL 5.6 mg and placebo. The
study did not reach statistical significance on the primary
endpoint. While there was nominal improvement by the
Week 4 visit on CAPS-5 (p=0.019), the improvement relative to
placebo was not sustained at Weeks 8 and 12. The CAPS-5 “sleep
disturbance” item also showed nominal improvement at Week 4
(p=0.002), as well as at Week 8 (p=0.026), but not thereafter. The
PROMIS Sleep Disturbance T-score also showed early nominal
improvement with TNX-102 SL 5.6 mg at Week 4 (p=0.015). It is also
notable that when the primary endpoint was analyzed for responder
rate, defined as ≥50% improvement on CAPS-5 total score at Week 4,
38.4% of those on TNX-102 SL were responders versus 24.4% on
placebo (p=0.019). TNX-102 SL was well-tolerated and the adverse
events reported were similar to those seen in prior TNX-102 SL
studies. There were three participants with serious adverse events
(SAEs) reported during the study: two in the placebo group and one
in the active group. None were deemed related to study drug.
Administration site reactions were similar in profile to prior
studies with TNX-102 SL, with oral numbness (hypoaesthesia) at the
highest rate. These oral sensory adverse events (AE), oral
numbness, oral tingling, and tongue discomfort were
temporally-related to dosing and were rated as mild and transient
(<60 min) in the majority of cases. No new safety signals were
observed.
In addition to the Phase 3 HONOR study described
in the published article1, Tonix has also studied TNX-102 SL in a
Phase 2 (‘AtEase’) trial in military PTSD5 and in a Phase 3
(‘RECOVERY’) trial in civilian PTSD.6 Both studies were performed
with the primary endpoint of CAPS-5 improvement at Week 12. AtEase
compared bedtime TNX-102 SL at two doses (2.8 mg & 5.6 mg) and
placebo. RECOVERY compared TNX-102 SL 5.6 mg and placebo. Neither
study reached statistical significance on the primary
endpoint.
Fibromyalgia: TNX-102 SL has
shown positive results in two Phase 3 clinical trials for the
management of fibromyalgia. Tonix plans to submit a New Drug
Application to the U.S. Food and Drug Administration in the second
half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for
the management of fibromyalgia.
Formulation Technology and
Patents: 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. TNX-102 SL is also in development for
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 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 cyclobenzaprine 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.
*TNX-102 SL has not been approved for any indication; name
conditionally approved by FDA as Tonmya™ for the management of
fibromyalgia
- Parmenter ME, et al. Psychiatry
Research. 2024. 334: 115764.
https://doi.org/10.1016/j.psychres.2024.115764.
- Tonix Press Release – September 27, 2023. “Tonix
Pharmaceuticals Announces Department of Defense Grant to Support
the University of North Carolina’s Proposed Investigator Sponsored
OASIS Trial of TNX-102 SL for Treatment of Acute Stress Reaction,
Acute Stress Disorder, and Posttraumatic Stress Disorder”.
https://bit.ly/3T1LyIl
- Tonix Press Release – Feb 12, 2024. “Tonix Pharmaceuticals
Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for
the Reduction of Acute Stress Reaction and Prevention of PTSD”
https://bit.ly/3TiQOsj.
- Schnurr, PP et al. Annals of Internal Medicine. 2024:
www.acpjournals.org/doi/10.7326/M23-2757.
- Sullivan GM, et al. Psychiatry Res.
2021. 301:113974.
https://doi.org/10.1016/j.psychres.2021.113974.
- Tonix Press
Release – December 21, 2020, “Tonix Pharmaceuticals Reports Topline
Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and
Outlines Future Development Plans” https://bit.ly/3uOgUu8
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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