Tonix Pharmaceuticals Enrolls First Participant in Military-Related PTSD Phase 3 Trial of FDA Breakthrough Therapy-Designated...
March 28 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, announced today that it has
enrolled the first participant in the Phase 3 HONOR study of
TNX-102 SL 5.6 mg, for the treatment of posttraumatic stress
disorder (PTSD).
"Enrolling the first participant in the HONOR study is an
important event not only to Tonix, but potentially to millions who
suffer worldwide from both civilian and military-related PTSD,"
said Seth Lederman, M.D., Tonix's president and chief executive
officer. “The HONOR study is designed to confirm the clinical
benefit of TNX-102 SL to improve PTSD symptoms across several
measures as demonstrated in our Phase 2 AtEase study in
military-related PTSD.”
About TNX-102 SL
TNX-102 SL is an investigational new drug and has not been
approved for any indication. It is a small,
rapidly-disintegrating sublingual tablet containing 2.8 mg of
cyclobenzaprine HCl for bedtime use. TNX-102 SL is a proprietary,
Protectic™ protective eutectic formulation of cyclobenzaprine that
allows for rapid systemic exposure and increased bioavailability
through transmucosal delivery. Tonix is developing TNX-102 SL 5.6
mg (2 x 2.8 mg tablets), as a potential treatment for PTSD. In the
Phase 2 AtEase study, TNX-102 SL 5.6 mg, taken sublingually at
bedtime for 12 weeks demonstrated activity for the treatment of
military-related PTSD compared to placebo, measured by a reduction
in the Clinician Administered PTSD Scale for DSM-5, or CAPS-5
score. The most frequently reported adverse events were episodes of
tongue numbness, which was generally transient and self-limited and
related to the oral site of administration. Systemic adverse events
included somnolence, dry mouth and sedation, which is similar to
the known side effects of oral cyclobenzaprine. In December 2016,
TNX-102 SL was granted Breakthrough Therapy designation by the U.S.
Food and Drug Administration (FDA) for the treatment of PTSD.
About the Phase 3 HONOR Study
HONOR is a Phase 3 randomized, double-blind, placebo-controlled
trial evaluating the efficacy of TNX-102 SL 5.6 mg, in participants
with military-related PTSD. The two-arm, adaptive design trial is
designed to enroll 550 participants across approximately 35 U.S.
sites. Participants in the HONOR study will be randomized to
receive either TNX-102 SL 5.6 mg (2 x 2.8 mg tablets), or placebo,
to be taken sublingually at bedtime daily for 12 weeks. The primary
endpoint is the mean change from baseline, after 12 weeks, in the
total CAPS-5 score compared between TNX-102 SL 5.6 mg, and placebo.
In an End-of-Phase 2/Pre-Phase 3 meeting with Tonix, the FDA
indicated its acceptance of Tonix’s proposed Phase 3 studies and
the planned New Drug Application data package for the registration
of TNX-102 SL for the treatment of PTSD. Tonix has received
FDA concurrence with the HONOR study design, including the proposal
for an unblinded interim analysis
(IA).
The HONOR study will have one unblinded IA by an independent data
monitoring committee when the study has results from approximately
50% efficacy-evaluable participants, or approximately 275
participants, which is projected to occur in the first half of
2018. If the IA results require continued enrollment, topline
results from the 550-participants trial are expected to be
available in the second half of 2018. Additional details of the
HONOR study are available at www.thehonorstudy.com, or
http://bit.ly/2lrMZ1H.
About Posttraumatic Stress Disorder
PTSD can develop from witnessing or experiencing a traumatic
event in which there was the severe threat of, or actual occurrence
of, grave physical harm or death. PTSD affects approximately 8.6
million Americans and is a chronic and severely debilitating
condition in which patients re-experience the horrific traumas that
resulted in the condition in the forms of intrusive memories,
flashbacks, and nightmares. PTSD typically is characterized by
disrupted sleep, anxiety, agitation, avoidance, emotional numbness
and estrangement from family and friends, guilt or negative beliefs
about self, and sometimes is associated with clinical depression
and suicidal thinking. Individuals who suffer from PTSD usually
have significant impairment in social functioning, occupational
disability, and an overall poor quality of life. PTSD is sometimes
associated with substance abuse and unpredictable violent or
suicidal behaviors. It is estimated that more than 19 percent
of the 1.9 million U.S. veterans who were deployed to the recent
conflicts in Iraq and Afghanistan suffer from PTSD.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to
address public health challenges. TNX-102 SL is in Phase 3
development and has been granted Breakthrough Therapy designation
by the FDA for the treatment of PTSD. 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. The Protectic™ protective eutectic and
Angstro-Technology™ formulation are essential elements of the
proprietary TNX-102 SL composition for which a Notice of Allowance
has been issued by the U.S. Patent and Trademark Office. Other
development efforts include TNX-601 (tianeptine oxalate), a
clinical candidate at Pre-IND (Investigational New Drug)
application stage, designed for daytime use for the treatment of
PTSD, and TNX-801, a potential smallpox-preventing vaccine based on
a live synthetic version of horsepox virus (HPXV). HPXV has
protective vaccine activity in mice, using a model of lethal
vaccinia infection.
This press release and further information about Tonix are
provided 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, 2015, as filed
with the Securities and Exchange Commission (the “SEC”) on March 3,
2016, 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 Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x185
Edison Advisors (investors)
Tirth Patel
tpatel@edisongroup.com
(646) 653-7035
Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588
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