Pipeline Expansion of Novel Innate Defense
Regulator Technology
PRINCETON, N.J., Nov. 30,
2023 /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
the U.S. Food and Drug Administration (FDA) has cleared the
Investigational New Drug (IND) application for a Phase 2a clinical
trial entitled, "Pilot Study of SGX945 (Dusquetide) in the
Treatment of Aphthous Ulcers in Behçet's Disease." The study is
designed to evaluate the safety and efficacy of SGX945 (dusquetide)
and is expected to begin patient enrollment in the second half of
2024.
"We are pleased to have received FDA clearance on our SGX945
Phase 2 pilot trial in aphthous ulcers of Behçet's disease," stated
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "Our previous
studies with dusquetide in oral mucositis have clearly validated
the biologic activity in aphthous ulcers induced by chemotherapy
and radiation. Given the role of the innate immune system in ulcers
associated with Behçet's Disease, and the unmet medical need
particularly for more severe ulcers such as genital and leg ulcers,
we believe that dusquetide may offer significant relief to
patients. We are excited to expand dusquetide's development into
different innate immune-related inflammatory conditions such as
Behçet's disease, as a component of our long-term strategy to
enhance the value of this unique compound. Behçet's disease is an
unmet medical need, with up to 18,000 people in the U.S., 80,000 in
Europe, 350,000 people in
Turkey and as many as 1 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."
Under this IND, the pilot clinical trial of SGX945 will be
an open-label study that will enroll approximately 25 patients age
18 years or older with mild to moderate Behçet's disease active
oral and/or genital ulcers. Patients will receive SGX945 as a twice
weekly 4-minute intravenous (IV) infusion for 4 weeks. Efficacy
endpoints will include the extent of lesion clearance, timeline to
lesion clearance, and patient reported quality of life indices.
About Dusquetide
Dusquetide (the active ingredient in SGX945 and SGX942 in
development for 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, including melioidosis. 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 (BD) is commonly known as an inflammatory
disorder of the blood vessels (vasculitis). Often first diagnosed
in young adults, it's 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.
BD 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 BD in the U.S. and 80,000 in Europe. There are as many as 1,000,000 people
worldwide living with BD.
There is no cure for BD, 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 BD 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 BD 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 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, the Company's preliminary prospectus
(Registration No. 333-271049) filed with the SEC on May 4, 2023, and 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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SOURCE SOLIGENIX, INC.