PRINCETON, N.J., Jan. 8, 2024 /PRNewswire/ -- Soligenix, Inc.
(Nasdaq: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need, announced today that its SGX945 (dusquetide) development
program for the treatment of oral lesions of Behçet's Disease
has received "Fast Track" designation from the U.S. Food and Drug
Administration (FDA).
Fast track is a designation that the FDA reserves for a drug
intended to treat a serious or life-threatening condition and one
that demonstrates the potential to address an unmet medical need
for the condition. Fast track designation is intended to facilitate
the development and expedite the review of new drugs and biologics.
For instance, should events warrant, Soligenix will be eligible to
submit a new drug application (NDA) for SGX945 on a rolling basis,
permitting the FDA to review sections of the NDA prior to receiving
the complete submission. Additionally, NDAs for fast track
development programs ordinarily will be eligible for priority
review, which imparts an abbreviated review time of approximately
six months.
"We are very pleased to have SGX945 in Behçet's Disease
granted fast track designation from the FDA," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "As demonstrated by the granting of
the designation, our previous studies with dusquetide in oral
mucositis have clearly validated the biologic activity in aphthous
ulcers induced by chemotherapy and radiation. Behçet's disease is
an unmet medical need in which the underlying vasculitis leads to
ulceration of the mucous membranes and skin, with up to 18,000
people in the U.S. and as many as one million people worldwide
affected by this incurable disease. Given our promising results
with aphthous ulcers in oral mucositis, we are hopeful dusquetide
will have a role to play in helping underserved patients suffering
from this difficult to treat and chronic disease and look forward
to initiating the Phase 2 clinical study in 2024."
About Dusquetide
Dusquetide (the active ingredient in SGX945 (Behçet's disease)
and SGX942 (oral mucositis)) is an innate defense regulator (IDR),
a new class of short, synthetic peptides. It has a novel mechanism
of action whereby it modulates the body's reaction to both injury
and infection towards an anti-inflammatory, anti-infective, and
tissue healing response. IDRs have no direct antibiotic activity
but, by modulating the host's innate immune system responses,
increase survival after infections caused by a broad range of
bacterial Gram-negative and Gram-positive pathogens. It also
accelerates resolution of tissue damage following exposure to a
variety of agents including bacterial pathogens, trauma, and chemo-
and/or radiation therapy. Preclinical efficacy and safety have been
demonstrated in numerous animal disease models including mucositis,
colitis, macrophage activation syndrome (MAS) as well as bacterial
infections. In addition, potential anti-tumor activity has been
demonstrated in multiple in vitro and in vivo
xenograft studies.
Dusquetide has demonstrated safety and tolerability in a Phase 1
clinical study in 84 healthy human volunteers. In Phase 2 and 3
clinical studies with SGX942 in over 350 subjects with oral
mucositis due to chemoradiation therapy for head and neck cancer,
positive efficacy results were demonstrated, including potential
long-term ancillary benefits.
Soligenix has a strong intellectual property position in the IDR
technology platform, including composition of matter for dusquetide
and related analogs. Dusquetide was developed pursuant to
discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD
of the University of British
Columbia, Canada.
About Behçet's Disease
Behçet's Disease is commonly known as an inflammatory disorder
of the blood vessels (vasculitis). Often first diagnosed in young
adults, its effects and severity will wax and wane over time. Major
signs and symptoms usually include mouth sores (approximately 95%
of patients), skin rashes and lesions (approximately 50% of
patients), genital sores (approximately 50% of patients), leg
ulcers (approximately 40% of patients) and eye inflammation
(approximately 15% of patients). It is a painful disease, directly
impacting the patient's quality of life and ability to productively
engage in life activities, including work.
Behçet's Disease is thought to be an auto-immune disease with
both genetic and environmental factors. It is most common along the
"Silk Road" in the Middle East and
East Asia, including Turkey, Iran,
Japan and China. There are approximately 18,000 known
cases of Behçet's Disease in the U.S. and 80,000 in Europe. There are as many as 1,000,000 people
worldwide living with Behçet's Disease.
There is no cure for Behçet's Disease, rather treatments are
prescribed to manage symptoms. Treatments may include both
maintenance therapies and those specifically addressing flares
(e.g., mouth ulcers, genital ulcers and leg ulcers).
Corticosteroids are generally applied topically to sores and as
eyedrops and may also be given systemically to reduce inflammation.
Although used frequently, they have limited efficacy over the
long-term and have significant side effects that become more
concerning with more chronic use. Genital ulcers are often
associated with significant genital scarring while leg ulcers can
result in a post-thrombotic syndrome. Other treatments for Behçet's
Disease flares involve suppressing the immune system with drugs
(e.g., cyclosporine or cyclophosphamide). These drugs come with a
higher risk of infection, liver and kidney problems, low blood
counts and high blood pressure. Finally, anti-inflammatory drugs
are also used, including anti-TNF medications. The only
approved drug in Behçet's Disease is apremilast, which is used as a
maintenance therapy to prevent formation of oral ulcers.
Unfortunately, apremilast is associated with both high cost and
side effects including diarrhea, nausea, upper respiratory tract
infection and headache.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our Specialized
BioTherapeutics business segment is developing and moving toward
potential commercialization of HyBryte™ (SGX301 or
synthetic hypericin sodium) as a novel photodynamic therapy
utilizing safe visible light for the treatment of cutaneous T-cell
lymphoma (CTCL). With a successful Phase 3 study completed,
regulatory approval is being sought and commercialization
activities for this product candidate are being advanced initially
in the U.S. Development programs in this business segment also
include expansion of synthetic hypericin (SGX302) into psoriasis,
our first-in-class innate defense regulator (IDR) technology,
dusquetide (SGX942) for the treatment of inflammatory diseases,
including oral mucositis in head and neck cancer, and (SGX945) in
Behçet's Disease. The Company also is developing proprietary
formulations of oral beclomethasone 17,21-dipropionate (BDP) for
the prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation such as pediatric Crohn's
disease (SGX203).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, as well as our vaccine programs targeting filoviruses
(such as Marburg, Sudan and Ebola)
and CiVax™, our vaccine candidate for the prevention of
COVID-19 (caused by SARS-CoV-2). The development of our vaccine
programs incorporates the use of our proprietary heat stabilization
platform technology, known as ThermoVax®. To date, this
business segment has been supported with government grant and
contract funding from the National Institute of Allergy and
Infectious Diseases (NIAID), the Defense Threat Reduction Agency
(DTRA) and the Biomedical Advanced Research and Development
Authority (BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at https://www.soligenix.com and follow
us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that
reflect Soligenix, Inc.'s current expectations about its
future results, performance, prospects and opportunities, including
but not limited to, potential market sizes, patient populations and
clinical trial enrollment. Statements that are not historical
facts, such as "anticipates," "estimates," "believes," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"potential," or similar expressions, are forward-looking
statements. These statements are subject to a number of risks,
uncertainties and other factors that could cause actual events or
results in future periods to differ materially from what is
expressed in, or implied by, these statements, and include the
expected amount and use of proceeds from the offering and the
expected closing date of the offering. Soligenix cannot assure you
that it will be able to successfully develop, achieve regulatory
approval for or commercialize products based on its technologies,
particularly in light of the significant uncertainty inherent in
developing therapeutics and vaccines against bioterror threats,
conducting preclinical and clinical trials of therapeutics and
vaccines, obtaining regulatory approvals and manufacturing
therapeutics and vaccines, that product development and
commercialization efforts will not be reduced or discontinued due
to difficulties or delays in clinical trials or due to lack of
progress or positive results from research and development efforts,
that it will be able to successfully obtain any further funding to
support product development and commercialization efforts,
including grants and awards, maintain its existing grants which are
subject to performance requirements, enter into any biodefense
procurement contracts with the U.S. Government or other countries,
that it will be able to compete with larger and better
financed competitors in the biotechnology industry, that changes in
health care practice, third party reimbursement limitations and
Federal and/or state health care reform initiatives will not
negatively affect its business, or that the U.S. Congress may not
pass any legislation that would provide additional funding for the
Project BioShield program. In addition, there can be no assurance
as to the timing or success of any of its clinical/preclinical
trials. Despite the statistically significant result achieved in
the HyBryte™ (SGX301) Phase 3 clinical trial for
the treatment of cutaneous T-cell lymphoma, there can be no
assurance that a marketing authorization from the FDA or EMA will
be successful. Notwithstanding the result in the
HyBryte™ (SGX301) Phase 3 clinical trial for the
treatment of cutaneous T-cell lymphoma and the Phase 2a clinical
trial of SGX302 for the treatment of psoriasis, there can be no
assurance as to the timing or success of the clinical trials of
SGX302 for the treatment of psoriasis. Despite the positive
efficacy results demonstrated in the Phase 2 and 3 clinical studies
of SGX942 for the treatment of oral mucositis due to chemoradiation
therapy for head and neck cancer, there can be no assurance as to
the timing or success of the clinical trials of SGX945 for the
treatment of Behçet's Disease. Further, there can be no assurance
that RiVax® will qualify for a biodefense Priority
Review Voucher (PRV) or that the prior sales of PRVs will be
indicative of any potential sales price for a PRV for
RiVax®. Also, no assurance can be provided that the
Company will receive or continue to receive non-dilutive government
funding from grants and contracts that have been or may be awarded
or for which the Company will apply in the future. These and other
risk factors are described from time to time in filings with the
Securities and Exchange Commission (the "SEC"), including, but not
limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless
required by law, Soligenix assumes no obligation to update or
revise any forward-looking statements as a result of new
information or future events.
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