Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the poster presentation of positive results from its
Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of
fibromyalgia. A copy of the poster will be made available under the
IR Events tab of the Investors section of the Tonix website at
www.tonixpharma.com.
The poster, titled, “Efficacy and Safety of
TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of
Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3
Randomized, Double-Blind, Placebo-Controlled Multicenter Trial”
shows that TNX-102 SL met its pre-specified primary endpoint in the
Phase 3 RELIEF trial, significantly reducing daily pain compared to
placebo (p=0.01) and was associated with a higher rate than placebo
of ≥30% pain responders in participants with fibromyalgia
(p=0.006). TNX-102 SL at 5.6 mg also showed activity in key
secondary endpoints measuring improvements in sleep quality,
mitigation of fatigue, and fibromyalgia-specific functional
recovery. In addition, TNX-102 SL was well tolerated and was not
associated with side-effects seen with other approved oral
fibromyalgia treatments, including weight gain, insomnia, nausea or
sexual dysfunction.
“We believe the results of the Phase 3 RELIEF
trial validate the mechanism that improved sleep quality can lead
to syndromal effects on fibromyalgia, improving not only pain but
also sleep and fatigue. The sublingual formulation of TNX-102 SL
for transmucosal absorption showed promise at the 2.8 mg dose in
prior fibromyalgia studies, but we believe RELIEF provides evidence
that 5.6 mg is the right dose for this patient population,” said
Seth Lederman, M.D., President and Chief Executive Officer. “We
expect interim analysis results for the confirmatory Phase 3 study,
RALLY, in the third quarter of this year, followed by topline data
in the first quarter of next year.”
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is
understood to result from amplified sensory and pain signaling
within the central nervous system. Fibromyalgia afflicts an
estimated 6-12 million adults in the U.S., approximately 90% of
whom are women. 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.
Physicians and patients report common dissatisfaction with
currently marketed products.
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride which 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 serotonin2A, α1-adrenergic,
histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in
clinical development as a daily bedtime treatment for fibromyalgia,
PTSD, alcohol use disorder and agitation in Alzheimer’s disease.
The U.S. Patent and Trademark Office (USPTO) has 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 these patents are important elements of Tonix’s
proprietary TNX-102 SL composition. These patents are expected to
provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity
until 2034/2035.
About the Phase 3 RELIEF
Study
The RELIEF study has been completed and TNX-102
SL achieved a statistically significant benefit as measured by the
primary, prespecified endpoint of improvement over placebo in daily
pain. The RELIEF study was a double-blind, randomized,
placebo-controlled Phase 3 trial designed to evaluate the efficacy
and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets)
for the management of fibromyalgia. The two-arm trial targeted
enrollment of 470 participants, at approximately 40 U.S. sites.
RELIEF completed final enrollment of 503 participants. The first
two weeks of treatment were a run-in period in which participants
start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first
two weeks, all participants had 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 was 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.
Additional details about the completed RELIEF
study are available at clinicaltrials.gov (NCT04172831), and study
results are detailed in the poster presentation at ASCP (available
under the IR Events tab of the Investors section of the Tonix
website at www.tonixpharma.com).
About the Phase 3 RALLY
Study
The ongoing RALLY study is also a double-blind,
randomized, placebo-controlled Phase 3 trial designed to evaluate
the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl
sublingual tablets). The trial design and endpoints are essentially
the same as the RELIEF study; however, the RALLY study is targeting
to enroll 200 more participants than the RELIEF study, for a total
of 670 participants at approximately 40 U.S. sites. RALLY has
already enrolled more than 335 participants for the interim cohort.
RALLY will have a planned interim analysis based on the first
approximately 335 recruited participants in which an independent
data monitoring board (IDMB) will make recommendations to the
company to stop early for success, continue as planned, add more
participants, or stop for futility. The interim analysis results
expected in the third quarter of 2021 followed by topline data in
the first quarter of 2022.
Additional details about the ongoing RALLY study
are available at clinicaltrials.gov (NCT04508621).
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
Company’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3
development for the management of fibromyalgia, with positive data
from the Phase 3 RELIEF study reported in December 2020. The
Company expects interim data from the second Phase 3 study, RALLY,
in the third quarter of 2021 and topline data in the first quarter
of 2022. Tonix’s immunology portfolio includes vaccines to prevent
infectious diseases and biologics to address immunosuppression,
cancer, and autoimmune diseases. Tonix’s lead vaccine candidate,
TNX-18002, is a live replicating vaccine based on the horsepox
viral vector platform to protect against COVID-19, primarily by
eliciting a T cell response. Tonix reported positive efficacy data
from animal studies of TNX-1800 in the first quarter of 2021.
TNX-8012, live horsepox virus vaccine for percutaneous
administration, is in development to protect against smallpox and
monkeypox.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.
2TNX-1800 and TNX-801 are investigational new
biologics 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, 2020, as filed with the Securities and
Exchange Commission (the “SEC”) on March 15, 2021, and periodic
reports filed with the SEC on or after the date thereof. All
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(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo
(investors)Westwicke/ICRpeter.vozzo@westwicke.com(443) 213-0505
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