Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 Trial of FDA-Designated Breakthrough Therapy Tonmya® (Cyclob...
April 03 2018 - 7:00AM
Phase 3 HONOR Study Enrollment Continues and
Interim Results of the First 50 Percent of Participants Expected in
Third Quarter 2018
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
clinical-stage biopharmaceutical company focused on developing
pharmaceutical products to treat serious neuropsychiatric
conditions and biological products to improve biodefense, announced
that 50 percent of the planned total number of participants have
been randomized in the Phase 3 HONOR study evaluating Tonmya®*, or
TNX-102 SL 5.6 mg, for the bedtime treatment of military-related
posttraumatic stress disorder (PTSD). Tonmya for the treatment of
PTSD has been designated a Breakthrough Therapy by the U.S. Food
and Drug Administration (FDA). Clinical evidence from the Phase 2
study of Tonmya showed a potential improvement over existing
therapies used to treat military-related PTSD. The FDA is committed
to expediting the development and review of Tonmya for PTSD.
An interim analysis of the first 50 percent of randomized
participants will be conducted shortly after the 12-week treatment
period has been completed by these participants. Topline efficacy
results from the interim analysis are expected in the third quarter
of this year.
"Reaching randomization of 50 percent for the HONOR study is an
important milestone for Tonix,” said Seth Lederman, M.D., President
and Chief Executive Officer. “Based on the current enrollment rate,
topline data from the full study is expected in the fourth quarter
of 2018, if 550 participants are needed to complete the study.”
The interim analysis will be reviewed by an Independent Data
Monitoring Committee, or IDMC, which will review unblinded data
from this first 50 percent of participants and make one of three
recommendations: (1) stop the trial for success; (2) continue to
enroll the full study as planned; or (3) continue to enroll with a
specified increase in the total number of participants in the full
study.
At the Cross-disciplinary Breakthrough Therapy meeting, the FDA
indicated that a single-study New Drug Application (NDA) approval
is possible, based on the interim or end-of-study analysis of the
HONOR study, if the results are statistically persuasive. The
company is ready to file an NDA for Tonmya for the treatment of
PTSD in 2019 in the event of a persuasive outcome of the HONOR
study.
*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 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 sublingual transmucosal tablet 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 U.S., 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 40 U.S. sites. An
unblinded interim analysis will be conducted now that the study has
accumulated efficacy results from approximately 275 randomized
participants. In a Cross-Disciplinary Breakthrough Therapy meeting,
the FDA confirmed that (i) a single-study 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.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense through potential medical counter-measures. Tonix’s lead
product candidate, Tonmya, or TNX-102 SL, is in Phase 3 development
as a bedtime treatment for PTSD. Tonix is also developing TNX-102
SL as a bedtime treatment for agitation in Alzheimer’s disease.
A Phase 2 IND (Investigational New Drug) application was
submitted in March 2018 after completion of a successful pre-IND
meeting with the FDA. TNX-601 (tianeptine oxalate) is in the
pre-IND application stage, also for the treatment of PTSD but
designed for daytime dosing. 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.
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, 2017, as filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2018, 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 (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com(646) 942-5588
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