Tonix Pharmaceuticals Announces that Breakthrough Therapy Designation Remains in Effect for Tonmya® for the Treatment of Pos...
April 22 2019 - 6:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company developing
pharmaceutical products to treat psychiatric and pain conditions,
and biological products to improve biodefense, today announced the
U.S. Food and Drug Administration (FDA) has withdrawn its
previously issued Breakthrough Therapy Designation Rescind letter
and confirmed that the Breakthrough Therapy designation granted in
December 2016 remains in effect for Tonmya* (cyclobenzaprine HCl
sublingual tablets) for the treatment of posttraumatic stress
disorder (PTSD), which is in Phase 3 development. Tonix also
announced that FDA has reversed itself and granted the Company a
meeting in June to present additional data to support continuing
Breakthrough Therapy designation.
On December 20, 2018 the FDA issued an Intent to Rescind
Breakthrough Therapy Designation letter and provided Tonix the
opportunity to request a meeting within 60 days to discuss
additional data to support continued Breakthrough Therapy
designation for Tonmya for PTSD. Although Tonix made a timely
meeting request on February 15, 2019, FDA unexpectedly denied the
request and issued Breakthrough Therapy Designation Rescind and
Meeting Denied letters on February 26, 2019, without considering
the additional data the Company planned to submit prior to the
requested meeting. On April 17, 2019, in response to a
request for reconsideration by the Company, the FDA acknowledged
that FDA should have first provided Tonix the opportunity to
discuss the matter and formally withdrew the Breakthrough Therapy
Designation Rescind letter and Meeting Denied letter. The FDA
granted the Company a meeting in June to discuss the rationale and
additional data for continued Breakthrough Therapy
designation. Once the meeting has been held and the FDA’s
review of new information is complete, a determination regarding
the status of Tonmya’s Breakthrough Therapy designation will be
made.
Breakthrough Therapy designation was granted for Tonmya for PTSD
based on retrospective analysis of the effect of Tonmya 5.6 mg in
the Phase 2 AtEase study in military-related PTSD, which showed a
substantial improvement over existing therapies. The Intent to
Rescind letter states the FDA’s position that “emerging data” on
Tonmya from the HONOR study no longer appears to support the
continuation of the Breakthrough Therapy designation. At the
upcoming June meeting with the FDA, the Company intends to provide
additional data and analyses related to the HONOR study and the
AtEase study, which the Company believes supports continued
Breakthrough Therapy designation.
Seth Lederman, M.D., President and Chief Executive Officer of Tonix
commented, “We are pleased to have the opportunity to meet with the
FDA to discuss our rationale and present additional data in support
of continued Breakthrough Therapy designation for Tonmya for PTSD,
our lead development program. In March, we announced the
start of enrollment for the Phase 3 RECOVERY trial in civilian and
military-related PTSD, and we expect topline data from this trial
in the first half of next year.”
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat
psychiatric and pain conditions, and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
program is for the development of Tonmya (TNX-102 SL), which is in
Phase 3 development as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for fibromyalgia and
agitation in Alzheimer’s disease under separate INDs to support
potential pivotal efficacy studies. The fibromyalgia program is in
Phase 3 development and the agitation in Alzheimer’s program is
Phase 2 ready. The agitation in Alzheimer’s disease IND has been
designated a Fast Track development program by the FDA.
TNX-601 (tianeptine oxalate) is in the pre-IND application stage,
also for the treatment of PTSD but using a different mechanism from
TNX-102 SL and designed for daytime dosing. TNX-601 is also in
development for a potential indication - neurocognitive dysfunction
associated with corticosteroid use. Phase 1 clinical study selected
oral formulation of TNX-601 will be conducted outside of the U.S.
in 2019. Tonix’s lead biologic candidate, TNX-801, is a
potential smallpox-preventing vaccine based on a live synthetic
version of horsepox virus, currently in the pre-IND application
stage.
*Tonmya has been conditionally accepted by the U.S. Food and
Drug Administration (FDA) as the proposed trade name for TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.
TNX-102 SL is an investigational new drug and has 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; 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, 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
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo (investors)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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