Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, announced positive results from
its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also
known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in
healthy adult male and female ethnic Japanese and Chinese
volunteers. Results indicate that key pharmacokinetic parameters of
cyclobenzaprine are comparable in ethnic Japanese and Chinese
volunteers to Caucasian volunteers from a prior PK study. Tonmya
was generally well tolerated in the ethnic Japanese and Chinese
healthy volunteers. The company expects these data to fulfill the
requirement for a bridging study, and to support regulatory filings
for clinical studies in Japan and China where cyclobenzaprine is a
new chemical entity (NCE). Tonix holds issued patents for market
exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.
This study characterized the PK profile and dose
proportionality of Tonmya following administration in 20 healthy
volunteers of documented Japanese or Chinese ancestry, and compared
these findings to an existing PK dataset conducted under similar
conditions in Caucasian volunteers.
“This bridging study is an important first step
as we begin evaluating the potential for approval and marketing
Tonmya in Japan and China. The results show a similar
pharmacokinetic profile in ethnic Japanese and Chinese volunteers
with a Caucasian comparator group,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “As a result, we
believe that these data, with supporting results recently reported
from the positive Phase 3 RESILIENT study, are the only clinical
data needed to support regulatory filings in Japan and China.”
Dr. Lederman continued, “With patents issued in
Japan, China, Hong Kong and Taiwan expected to provide market
exclusivity into 2034, we believe that Tonmya would be a welcome
addition to the therapeutic options for fibromyalgia patients in
East Asia and an attractive asset for the right development and
commercialization partners in these markets. Cyclobenzaprine is an
NCE in both of these countries. We plan to meet with Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA) and China’s
National Medical Products Administration (NMPA) to seek agreement
on the development of Tonmya in Japan and China, respectively.”
About the Asia Bridging
Study
The study was a randomized, single-dose,
open-label, 2-way, crossover study design in ethnic Japanese (N=10)
and Chinese (N=10) healthy male and female volunteers. The primary
objective of the study was to characterize the PK profile and dose
proportionality of Tonmya following administration of 2.8 mg and
5.6 mg (one and two 2.8 mg tablets) under fasting conditions in
Japanese and Chinese volunteers, and to retrospectively compare
these PK data with existing PK data of both cyclobenzaprine and
norcyclobenzaprine from a prior Phase 1 study in Caucasian
volunteers dosed under the same conditions. Safety and tolerability
were also assessed. A 2.8 mg or 5.6 mg dose (2 X 2.8 mg tablet) of
Tonmya was administered sublingually in the morning under fasted
conditions. Blood samples were collected pre-dose and up to 15 days
post-dose for analyte measurements, with a 28-day washout between
periods. The primary PK endpoints were the total amount of
cyclobenzaprine and metabolite norcyclobenzaprine in the blood
(expressed as the area under the curve (AUC0-T)) and maximum
concentration (expressed as Cmax).
Study Results
PharmacokineticsEthnic Japanese and Chinese
volunteers were considered comparable on PK parameters for
cyclobenzaprine following a 2.8 mg and 5.6 mg dose of Tonmya, and
dose proportionality was demonstrated in both samples. Given that
the similarity in PK profile between Japanese and Chinese
volunteers was confirmed, the PK data from the two ethnic groups
were pooled for the comparison between Asian (n=20) and Caucasian
(n=16) volunteers. The PK parameters of cyclobenzaprine for
Japanese, Chinese, and Caucasian groups were similar, with
geometric mean ratios falling within the 90% confidence
interval.
Safety
- Tonmya was shown to
be safe and well-tolerated at doses up to 5.6 mg as single
sublingual administrations in healthy adult Japanese and Chinese
volunteers.
- The incidence of
adverse events (AEs) and investigational product-related AEs was
low. No volunteer discontinued due to an AE.
- No clinically
significant abnormal findings in laboratory parameters, ECGs, or
other safety assessments were noted during the study. No severe AEs
and no deaths were reported during the study.
Issued Patents in Japan, China, Hong
Kong and Taiwan
EUTECTIC FORMULATIONS |
Country |
Patent Number |
Expected Expiry |
China |
ZL 201480024011.1 |
03/14/2034 |
China |
ZL201910263541.6 |
03/14/2034 |
Hong Kong |
HK1218727 |
03/14/2034 |
Japan |
6310542 |
03/14/2034 |
Taiwan R.O.C. |
I661825 |
03/14/2034 |
TRANSMUCOSAL ABSORPTION |
Japan |
6259452 |
06/14/2033 |
Taiwan R.O.C. |
I590820 |
06/14/2033 |
Taiwan R.O.C. |
I683660 |
06/14/2033 |
Taiwan R.O.C. |
I642429 |
06/14/2033 |
Hong Kong |
1209361 |
06/14/2033 |
About Tonmya* (also known as TNX-102
SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. The tablet is a patented
sublingual formulation of cyclobenzaprine hydrochloride developed
for the management of fibromyalgia. In December 2023, the Company
announced highly statistically significant and clinically
meaningful topline results in RESILIENT, a second positive Phase 3
clinical trial of Tonmya for the management of fibromyalgia. In the
study, Tonmya met its pre-specified primary endpoint, significantly
reducing daily pain compared to placebo (p=0.00005) in participants
with fibromyalgia. Statistically significant and clinically
meaningful results were also seen in all key secondary endpoints
related to improving sleep quality, reducing fatigue and improving
overall fibromyalgia symptoms and function. RELIEF, the first
positive Phase 3 trial of Tonmya in fibromyalgia, was completed in
December 2020. It met its pre-specified primary endpoint of daily
pain reduction compared to placebo (p=0.010) and showed activity in
key secondary endpoints.
Tonix plans to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) in the second
half of 2024 for Tonmya for the management of fibromyalgia.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
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.com443-213-0495
Tonix Pharmaceuticals (NASDAQ:TNXP)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024