Tonix Pharmaceuticals Presented Analyses of Potential Moderators of Treatment Response to U.S. FDA-Designated Breakthrough Th...
May 22 2017 - 4:05PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, presented a poster on May 20,
2017, entitled “Phase 2 Multisite Double-Blind Placebo-Controlled
Trial of TNX-102 SL in Military-Related Posttraumatic Stress
Disorder: Mediators and Moderators of Treatment Response” (Poster
No. 3001130) at the 72nd Annual Scientific Convention of the
Society of Biological Psychiatry in San Diego. The poster can be
found on the Scientific Presentations page on Tonix’s website. A
moderator is a characteristic of study participants that is
associated with a treatment response.
Baseline posttraumatic stress disorder (PTSD) severity threshold
and combat trauma-related PTSD were two potential moderators of
treatment response that were further examined. A retrospective
analysis of the Phase 2 AtEase* data indicated a study entry
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) severity score
of ≥33 is more aligned with the entry criteria of previous PTSD
pharmacotherapy registration trials using prior CAPS
versions. In the AtEase CAPS-5 ≥33 subset, the effect size of
TNX-102 SL** 5.6 mg is approximately 0.5 on total CAPS-5 and also
approximately 0.5 on cluster B (intrusion) and cluster E (arousal
and reactivity) scores. Another potential moderator of
treatment response was combat trauma, and the subgroup of AtEase
with PTSD from combat-type traumas had statistically significant
effects of TNX-102 SL 5.6 on CAPS-5 total severity and cluster B
and cluster E, and on overall functional improvement by Sheehan
Disability Scale total score, work and social items. TNX-102 SL was
well-tolerated with a high completion rate in AtEase. There
were no adverse event-related discontinuations; non-dose related
tongue numbness was common, generally transient, and never rated as
severe. No clinically significant changes in weight or vital signs
over the 12 weeks of study were observed.
Seth Lederman, M.D., president and chief executive officer of
Tonix, commented, “We continue to work with the U.S. Food and Drug
Administration (FDA) to accelerate the development and registration
of TNX-102 SL for PTSD. Our Phase 3 HONOR study is
currently enrolling participants with military-related PTSD. A
planned unblinded interim analysis on approximately 50% of the
randomized participants (N=275) is on track for the first half of
2018.”
* AtEase is a Phase 2 multicenter, 12-week, double-blind
placebo-controlled study conducted at 24 U.S. sites in men and
women ages 18-65 years. Inclusions: PTSD DSM-5 Criterion A
trauma(s) incurred during military service since 2001; screening
and baseline CAPS-5 score ≥29; free of antidepressants ≥2 months
from baseline; free of or washed off from other psychotropics; not
participating in trauma-focused psychotherapy within a month from
baseline. Exclusions: serious suicide risk; substance/alcohol use
disorders within 6 months; lifetime bipolar I or II, psychotic,
obsessive-compulsive, or antisocial personality disorders.
Participants were randomized in 2:2:1 ratio to placebo, TNX-102 SL
2.8 mg or TNX-102 SL 5.6 mg. Primary analysis: comparison of mean
change from baseline at Week 12 in CAPS-5 score between TNX-102 SL
2.8 mg and placebo.
**TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is
an investigational new drug and has not been approved for any
indication.
About TNX-102 SL and the Phase 3 HONOR
Study
TNX-102 SL 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, TNX-102 SL 5.6 mg
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 TNX-102
SL 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 TNX-102 SL 5.6 mg in participants
with military-related PTSD. This two-arm, adaptive-design trial is
targeting enrollment of up to approximately 550 participants across
approximately 35 clinical 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 meeting, the FDA confirmed that a
single-study new drug application (NDA) approval could be possible
if the topline data from the HONOR study are statistically very
persuasive. 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 TNX-102 SL formulation. The Protectic™ protective eutectic
and Angstro-Technology™ formulation claimed in the patent are
important elements of Tonix’s proprietary TNX-102 SL
composition. This patent is expected to provide TNX-102 SL
with U.S. market exclusivity until 2034 upon NDA approval.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical products to
address major public health challenges. In addition to TNX-102 SL
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 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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