Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Plans to Expand TNX-102 SL Phase 3 Program Beyond PTSD to Include Fibromyalgia
FDA Meeting Minutes Support Phase 3 Development of TNX-102 SL 5.6 mg in Fibromyalgia
YORK, April 4, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage
biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric and central nervous
system conditions, and biological products to improve biodefense, announced today the expansion of the TNX-102 SL 5.6 mg program
beyond posttraumatic stress disorder (PTSD) to include a Phase 3 development for TNX-102 SL* in fibromyalgia. TNX-102 SL or Tonmya **
is Tonix's lead Phase 3 program in PTSD with the Phase 3 RECOVERY trial actively enrolling military and civilian PTSD participants.
a recent Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received clear guidance and support
to advance the development of TNX-102 SL, a non-opioid centrally-acting analgesic, for the management of fibromyalgia. Acceptable
study design features were discussed to establish the safety and efficacy of TNX-102 SL 5.6 mg in a pivotal study to support the
fibromyalgia indication.
lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase
3 study. Both studies showed clinical benefits especially in the quality of sleep improvement, however, primary analyses on pain
reduction were not statistically significant. Additional data developed by Tonix in the PTSD program showed that TNX-102 SL 5.6
mg (2 x 2.8 mg tablets) demonstrated acceptable tolerability with additional clinical benefit in pain reduction for trial participants
with PTSD. There were no serious and/or unexpected adverse events reported; the most common adverse events were mostly related
to local administration site reactions, such as oral hypoaesthesia and abnormal product taste.
by the safety and efficacy findings in PTSD, Tonix believes that increasing the dose of TNX-102 SL from 2.8 mg to 5.6 mg in the
new Phase 3 fibromyalgia study may provide clinical evidence to support the 5.6 mg dose as the efficacious dose for the management
of fibromyalgia. The registration of TNX-102 SL 5.6 mg for the fibromyalgia indication will be supported by two positive Phase
3 studies, and the long-term safety exposure data from the PTSD program may support the fibromyalgia NDA.
are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program
with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD. FDA's acceptance of the well-established
safety information of currently marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure
data from our PTSD studies may support the fibromyalgia indication is very reassuring. We are looking forward to submit a final
Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation." said Seth Lederman, M.D.,
Tonix's President and Chief Executive Officer. "We have extensive clinical experience and data collected over the past 7
years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we
are very pleased with the FDA clear guidance and support to help advancing our lead product candidate, TNX-102 SL, in fibromyalgia
and PTSD toward NDA approvals."
Lederman continued, "There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering
that approximately one-third of fibromyalgia patients are on chronic opiates. Tonix could potentially address this need for a
non-opiate, non-addictive analgesic for fibromyalgia and possibly other indications in which improvement in sleep quality can
indirectly provide clinical benefit to the primary symptoms."
is a chronic neurobiological disorder that is thought to result from amplified sensory and pain signaling. Fibromyalgia afflicts
five to 15 million Americans, and physicians and patients report widespread dissatisfaction with currently marketed products.
Common symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated
symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia
struggle with their daily activities, have impaired quality of life, and frequently are disabled.
Tonix Pharmaceuticals Holding Corp.
is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric
and central nervous system 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 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.
SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.
has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL for the
press release and further information about Tonix can be found at www.tonixpharma.com.
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.