Tonix Pharmaceuticals Reports Outcomes from U.S. FDA Breakthrough Therapy CMC Guidance Meeting of Tonmya® (Cyclobenzaprine H...
October 17 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical and biological
products to address public health challenges, announced today the
receipt of official minutes from a chemistry, manufacturing and
controls (CMC) guidance meeting with the U.S. Food and Drug
Administration (FDA) regarding the CMC data required to support the
Tonmya* (cyclobenzaprine HCI sublingual tablets), or TNX-102 SL,
New Drug Application (NDA) and the commercial product. Tonix
is in Phase 3 development of Tonmya, an FDA-designated Breakthrough
Therapy for the treatment of posttraumatic stress disorder (PTSD).
Seth Lederman, M.D., president and chief
executive officer of Tonix, stated, “Tonix has been successfully
implementing the commercial production strategy for TNX-102 SL in
addition to manufacturing final drug product to support the
required clinical studies for the Tonmya NDA. The CMC
guidance meeting we had with the FDA in September is part of our
effort to ensure our NDA CMC plan is supportive of the Tonmya’s
registration plan, which is usually a big challenge for an
accelerated Breakthrough Therapy development program. In general,
our proposed CMC data package to support the Tonmya’s NDA and
commercial manufacturing plans was accepted by the FDA. The
FDA official minutes reflect our readiness to manufacture Tonmya
commercial product at production scale, which is critical to the
successful launch of a potentially improved treatment option for
PTSD patients, especially those patients with military-related
PTSD.”
*Tonmya has been conditionally accepted by the
FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl
sublingual tablets) for PTSD. TNX-102 SL is an investigational new
drug and has not been approved for any indication.
About Tonmya and the Phase 3 HONOR Study
Tonmya is a patented sublingual transmucosal
formulation of cyclobenzaprine that is in Phase 3 development. PTSD
is a serious condition characterized by chronic disability,
inadequate treatment options, especially for military-related PTSD,
and an overall high utilization of healthcare services that
contributes to significant economic burdens. In a Phase 2 study,
Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in
treating military-related PTSD, which formed the basis of the
Breakthrough Therapy designation granted by the FDA. Tonix is
currently conducting a Phase 3 trial of Tonmya in military-related
PTSD in the United States, the HONOR study, which is a 12-week
randomized, double-blind, placebo-controlled trial evaluating the
efficacy of Tonmya 5.6 mg in participants with military-related
PTSD. This two-arm, adaptive-design trial is targeting enrollment
of up to approximately 550 participants in approximately 45 U.S.
sites. An unblinded interim analysis will be conducted once the
study has accumulated efficacy results from approximately 275
randomized participants. In a recent Cross-Disciplinary
Breakthrough Therapy meeting, the FDA confirmed that (i) a
single-study new drug application (NDA) approval could be possible
if the topline data from the HONOR study are statistically very
persuasive, and (ii) an additional abuse assessment study is not
required for the NDA filing. Additional details of the HONOR study
are available at www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent
and Trademark Office has issued a patent (U.S. Patent No.
9,636,408) protecting the composition and manufacture of the unique
Tonmya formulation. The Protectic™ protective eutectic and
Angstro-Technology™ formulation are important elements of Tonix’s
proprietary Tonmya composition. This patent is expected to provide
Tonmya, upon NDA approval, with U.S. market exclusivity until
2034.
Tonix was awarded European patent (Patent No.
2501234, “Methods and Compositions for Treating Symptoms Associated
with Posttraumatic Stress Disorders Using Cyclobenzaprine”). This
patent is expected to provide Tonmya, upon European marketing
authorization, with European market exclusivity until November 2030
and the exclusivity may be extended based on the timing of the
European marketing authorization of Tonmya for PTSD.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical
and biological products to address major public health challenges.
In addition to Tonmya for PTSD, Tonix is developing TNX-601
(tianeptine oxalate), a clinical candidate at pre-IND
(Investigational New Drug) application stage, designed as a daytime
treatment for PTSD and TNX-801, a live synthetic version of
horsepox virus, at the pre-IND application stage, to be developed
as a potential smallpox-preventing vaccine.
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,
substantial competition; 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 risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. 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, 2016, as filed with the Securities and Exchange
Commission (the “SEC”) on April 13, 2017, and future periodic
reports filed with the SEC on or after the date hereof. 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 hereof.
Contacts
Jessica MorrisInvestor
Relationsinvestor.relations@tonixpharma.com(212) 980-9159
Russo Partners (media)Rich
Allanrich.allan@russopartnersllc.com(646) 942-5588
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