Study DUS-AUBD-01 opens patient
enrollment
PRINCETON, N.J., Nov. 14,
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 it has opened patient enrollment for its Phase 2 study
(protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the
treatment of Behçet's Disease.
"We are pleased to have received FDA clearance and Turkish
Medicines and Medical Devices Agency (Turkey's Ministry of Health) authorization to
start patient enrollment into our SGX945 Phase 2a 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 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 area of unmet medical need, with
up to 18,000 people in the U.S., 50,000 in Europe, 350,000 people in Turkey and as many as 1 million people
worldwide affected by this incurable disease. Given the promising
biologic activity observed 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 auto-immune disease. We look forward to completing
enrollment and announcing study results in the first half of
2025."
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 and active oral and/or
genital ulcers. Patients will receive SGX945 as a twice weekly
4-minute intravenous (IV) infusion for 4 weeks followed by 4 weeks
of follow-up. Efficacy endpoints will include the extent of lesion
clearance, timeline to lesion clearance, and patient reported
quality of life assessments.
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
Gram-negative and Gram-positive bacterial pathogens. Dusquetide
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 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 dusquetide 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 over 50,000 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 must be used continuously to be effective
and is associated with both high cost and side effects including
diarrhea, nausea, upper respiratory tract infection and
headache.
About Soligenix
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 successful completion of the second Phase 3 study,
regulatory approvals will be sought to support potential
commercialization worldwide. 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.
Our Public Health Solutions business segment includes
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's current expectations about its future results,
performance, prospects and opportunities, including but not limited
to, potential market sizes, patient populations, clinical trial
enrollment, the expected timing for closing the offering described
herein and the intended use of proceeds therefrom. 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 first
HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of
cutaneous T-cell lymphoma, there can be no assurance that the
second HyBryte™ (SGX301) Phase 3 clinical trial will be successful
or that a marketing authorization from the FDA or EMA will be
granted. Additionally, although the EMA has agreed to the key
design components of the second HyBryte™ (SGX301) Phase 3 clinical
trial, no assurance can be given that the Company will be able to
modify the development path to adequately address the FDA's
concerns or that the FDA will not require a longer duration
comparative study. Notwithstanding the result in the first 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. Additionally, despite the biologic activity observed in
aphthous ulcers induced by chemotherapy and radiation, 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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SOURCE SOLIGENIX, INC.