Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced that the first participant was enrolled in the Phase 3
RALLY study (TNX-CY-F306) of TNX-102 SL 5.6 mg for the management
of fibromyalgia.
RALLY is the Company’s second of two potentially
pivotal Phase 3 studies of TNX-102 SL, a proprietary sublingual
tablet formulation of cyclobenzaprine HCl taken daily at bedtime
for the management of fibromyalgia.
“This is an important milestone for Tonix and
potentially for the nation’s roughly 8 million adult fibromyalgia
sufferers,” said Seth Lederman, M.D., President and Chief Executive
Officer. “Our team is dedicated to advancing TNX-102 SL, which is
being developed as a novel, non-opioid, non-addictive,
centrally-acting analgesic.”
“Not only has the number of fibromyalgia
sufferers remained high, the stigma associated with a fibromyalgia
diagnosis has decreased due to greater knowledge of the
neurobiological underpinnings,” Dr. Lederman continued. “And many
people with fibromyalgia are still dissatisfied with available
treatments. Tolerability can be a problem for some with the
approved medications. Addiction can be a problem with off-label use
of opiates. TNX-102 SL has the potential to provide relief
from the pain, fatigue, sleep disturbance and dysfunction from
fibromyalgia with good tolerability and without addictive
potential.”
Both of the current Phase 3 trials are studying
TNX-102 SL at a dose of 5.6 mg which is twice the 2.8 mg dose used
in the Company’s prior Phase 2 and 3 studies in fibromyalgia.
Tolerability of the higher dose was documented in an earlier Phase
3 trial of TNX-102 SL in posttraumatic stress disorder
(PTSD). Both of the current Phase 3 fibromyalgia studies are
being conducted using essentially the same protocol.
An interim analysis of the first of the current
fibromyalgia trials, RELIEF, is expected by the end of September,
with topline results expected by year end. If the RALLY study
maintains current enrollment timelines and objectives, it is
expected to report topline data in the second half of next
year. Positive outcomes in both studies may potentially put
Tonix in a position to file a New Drug Application (NDA) with the
FDA for marketing approval in the second half of 2022.
About the Phase 3 RALLY
Study
The RALLY study is a double-blind, randomized,
placebo-controlled trial designed to evaluate the efficacy and
safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The
two-arm trial is expected to enroll approximately 470 patients
across approximately 40 U.S. sites. For the first two weeks of
treatment, there will be a run-in period in which patients will
start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first
two weeks, all patients will have the dose increased to TNX-102 SL
5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks.
The primary endpoint is daily diary pain severity score change
(TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly
averages of the daily numerical rating scale scores), analyzed by
mixed model repeated measures with multiple imputation.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is
thought to result from amplified sensory and pain signaling.
Fibromyalgia afflicts an estimated 6-12 million adults in the U.S,
and physicians and patients report widespread dissatisfaction with
currently marketed products. Common 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.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix’s portfolio is primarily composed of
central nervous system (CNS) and immunology product candidates. The
immunology portfolio includes vaccines to prevent infectious
diseases and biologics to address immunosuppression, cancer and
autoimmune diseases. The CNS portfolio includes both small
molecules and biologics to treat pain, neurologic, psychiatric and
addiction conditions. Tonix’s lead vaccine candidate, TNX-1800*, is
a live replicating vaccine based on the horsepox viral vector
platform to protect against COVID-19, primarily by eliciting a T
cell immune response. Tonix expects data from animal studies of
TNX-1800 in the fourth quarter of this year. TNX-801*, live
horsepox virus vaccine for percutaneous administration, is in
development to protect against smallpox and monkeypox and serves as
the vector platform on which TNX-1800 is based. Tonix is also
developing TNX-2300*, a second live replicating vaccine candidate
for the prevention of COVID-19 which employs bovine parainfluenza
virus as the vector. Tonix’s lead CNS candidate, TNX-102 SL**, is
in Phase 3 development for the management of fibromyalgia. The
Company expects results from an interim analysis in September 2020
and topline data in the fourth quarter of 2020. TNX-102 SL is also
in development for agitation in Alzheimer’s disease and alcohol use
disorder (AUD). Both the agitation in Alzheimer’s disease and AUD
programs are Phase 2 ready, and the agitation in Alzheimer’s
disease program has FDA Fast Track designation. Tonix‘s
programs for treating addiction conditions also include TNX-1300*
(T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution),
which is in Phase 2 development for the treatment of
life-threatening cocaine intoxication and has FDA Breakthrough
Therapy designation. TNX-601 CR** (tianeptine oxalate
controlled-release tablets) is another CNS program, currently in
Phase 1 development as a once-daily treatment for depression, while
TNX-1900**, intranasal oxytocin, is in development as a
non-addictive treatment for migraine and cranio-facial pain.
Tonix’s preclinical pipeline includes TNX-1600** (triple reuptake
inhibitor), a new molecular entity being developed as a treatment
for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being
developed to prevent and treat organ transplant rejection and
autoimmune conditions; and TNX-1700* (rTFF2), a biologic being
developed to treat gastric and pancreatic cancers.
*TNX-1800, TNX-801, TNX-2300, TNX-1300, TNX-1500
and TNX-1700 are investigational new biologics and have not been
approved for any indication.
**TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900
are investigational new drugs and have not been approved for any
indication.
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 failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and
Exchange Commission (the “SEC”) on March 24, 2020, 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.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Travis Kruse (media)Russo
Partnerstravis.kruse@russopartnersllc.com(212) 845-4272
Peter Vozzo
(investors)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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