Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals Presented Data from
Two Posters on TNX-102 SL for Reduction of Acute Stress Reaction and Prevention of PTSD and One Poster for Wound Healing at the 2024 Military
Health System Research Symposium (MHSRS)
Investigator-initiated Phase 2 trial to evaluate
TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic
stress disorder (PTSD) expected to begin third quarter 2024
Currently, no medication approved at or near
point-of-care to treat patients suffering from traumatic events and support their long-term health
CHATHAM, N.J., August 29, 2024 (GLOBE
NEWSWIRE) - 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 clinical data on? acute stress reaction and prevention of PTSD
data of TNX-102 SL in two poster presentations and presented preclinical data demonstrating automated high-throughput assay enabling screening
for therapeutics to accelerate wound healing in a third poster presentation at the 2024 Military Health System Research Symposium (MHSRS),
held August 26-29, 2024, in Kissimmee, Fla. Copies of the Company's posters, titled:
"Two Clinical Trials of Bedtime
Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic Stress Disorder (PTSD) Provide Rationale to Study TNX-102 SL
in the Aftermath of Trauma to Reduce Acute Stress Disorder (ASD) and Prevent PTSD";
"Development of the AURORA Platform
Trial Network to Test Interventions to Reduce Acute Stress Reaction Symptoms, and Illustration of Use Testing Sublingual Cyclobenzaprine
"Integrating Automated High-Throughput
Scratch Assay and Cell Painting for Comprehensive Analysis of Cell Migration and Wound Healing", are available under the Scientific
Presentations tab of the Tonix website at www.tonixpharma.com.
TNX-102 SL is being evaluated for the reduction
in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) when
administered within 24 hours of trauma event. In two double-blind, randomized clinical trials of military-related PTSD, TNX-102 SL showed
effects on sleep and PTSD symptoms in two and four weeks of treatment1. Supportive data on the effects of TNX-102 SL on reducing
PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential to reduce ASR/ASD symptoms which
are similar to those of PTSD2,3. TNX-102 SL has been well-tolerated with no recognized liability for tolerance or abuse. Data
from these trials support testing of TNX-102 SL within 24 hours of index trauma for effects on acute stress reaction (ASR) symptoms and
the incidence of PTSD. In the U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial conducted
by the University of North Carolina under an investigator-initiated investigational new drug (IND) application, 14 days of bedtime TNX-102
SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to
target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The results may ultimately
provide military personnel with a new treatment option that, when administered in the early aftermath of a traumatic event to individuals
with ASR symptoms, improves warfighter function.
"In previous trials, TNX-102 SL has been
shown to improve sleep quality in PTSD and increased activity on sleep and stress-related symptoms in the first several weeks of treatment
after a trauma event", said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Since sleep disturbance
plays a critical role in the development and maintenance of PTSD, sleep improvements may reorient the trajectory of posttraumatic pathology
from acute trauma towards early recovery. The OASIS study is driven by the observation that the symptoms of ASR and PTSD are similar and
by the hypothesis that TNX-102 SL's effect on sleep quality may reduce ASR symptoms, potentially providing military personnel, veterans,
and civilians with a new treatment option that, when administered in the early aftermath of a traumatic event, improves recovery, job
performance, and quality of life."
The investigator-initiated OASIS trial will
examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the
emergency department (ED) after a motor vehicle collision. The trial plans to enroll approximately 180 trauma survivors at ED study sites
around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo. The first
participant for the OASIS trial is expected to enroll in the third quarter of 2024.
The OASIS trial will build upon a foundation
of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative
to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding
from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading
tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.
Acute and chronic stress disorders can affect
both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience
at least one trauma in their lives.4 In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation
after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event
during their service.5 Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with
The third poster, titled "Integrating Automated High-Throughput
Scratch Assay and Cell Painting for Comprehensive Analysis of Cell Migration and Wound Healing", demonstrated optimization of
a highly efficient scratch-wound assay development method. The scratch-wound assay, commonly used to study wound healing, has limitations
that the study addresses by introducing an automated miniaturized high-throughput wound healing assay, enabling mass screening and identification
of novel therapies for wound-healing. The screening technology was merged with cell-painting to allow discovery of morphological characteristics
to identify mechanism of action of drugs for wound healing.
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 recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a
contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200 small molecule
broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of
military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research
facility in Frederick, MD. The company's Good Manufacutring Practice (GMP)-capable advanced manufacturing facility in
Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or
international emergency. 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 TNX-102 SL, a product candidate for
which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast
Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress
reaction. 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.
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