Clear biological signal demonstrated; additional patients
to be enrolled
PRINCETON, N.J., July 11,
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
the expansion of its Phase 2a trial of SGX302 (synthetic hypericin)
for the treatment of mild-to-moderate psoriasis after demonstration
of biological effect in the initial five subjects. The study
is expected to enroll at least an additional five subjects,
exploring the use of SGX302 in the standard of care psoriasis
setting, prior to undertaking the larger phase of the
study.
Evaluation of the initial five subjects enrolled demonstrated a
clear biological signal, with the majority of patients recording an
improvement in the PASI (psoriasis area and severity index) score.
Enrolling additional patients will enable Soligenix to evaluate the
use of SGX302 in the context of accelerated light treatment and
additional adjunct treatment.
"Patients with mild-to-moderate disease do not qualify for the
use of biologics and have fewer treatment options. The patients
enrolled in this study all demonstrated clinical improvement and,
with the experience gained in this first portion of the study, we
anticipate being able to further improve responses as we move
forward," stated Neal Bhatia, MD,
Director of Clinical Dermatology at Therapeutics Clinical Research
in San Diego and Chair of the
Company's Psoriasis MAB. "Having previously participated in the
positive Phase 3 clinical trial of HyBryte™ (synthetic hypericin)
in the treatment of cutaneous T-cell lymphoma (CTCL), I have had a
clinical interest in this novel therapy and am pleased that the
Soligenix team is advancing synthetic hypericin in psoriasis where
there remains an unmet medical need. Similar to CTCL, psoriasis is
a chronic disease where the management of side effects and
toxicities is as important as the management of the disease itself.
Psoriasis affects more than 7.5 million patients in the U.S. alone,
and 60-125 million people worldwide. Having treated psoriasis
patients for over 20 years and seen first-hand how they struggle to
find good treatment options, access to an additional effective and
safe therapy would add significantly to patient care and quality of
life for many people that are living with this disease. I look
forward to working with my esteemed colleagues to support Soligenix
in advancing this important development program forward."
"We are pleased with the initial results from our Phase 2a
trial," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "The expansion of this psoriasis study continues our
evaluation of synthetic hypericin into other disease indications,
including non-orphan indications, where there remains an unmet
medical need. Current estimates show as many as 60-125 million
people worldwide living with the condition, with a global treatment
market valued at approximately $15
billion in 2020 and projected to reach as much as
$40 billion by 2027. The
success of HyBryte™ in targeting malignant T-cells during CTCL
clinical trials is a promising indicator of the ability of SGX302
to provide a much-needed approach for the treatment of
mild-to-moderate psoriasis, also caused by dysregulated T-cells. We
anticipate being in a position to report additional SGX302 study
data before year-end, as well as the outcome of our ongoing
discussions with the FDA regarding a feasible and executable trial
design for a confirmatory Phase 3 study with HyBryte™ in the
treatment of early stage CTCL."
About Synthetic Hypericin
Visible light-activated synthetic hypericin is a novel,
first-in-class, photodynamic therapy (PDT) that is expected to
avoid many of the long-term risks associated with other PDT
treatments. Synthetic hypericin is a potent photosensitizer that is
topically applied to skin lesions and absorbed by cutaneous
T-cells. With subsequent activation by safe, visible light, T-cell
apoptosis is induced, addressing the root cause of psoriasis
lesions. Other PDTs have shown efficacy in psoriasis with a similar
apoptotic mechanism, albeit using ultraviolet (UV) light associated
with more severe potential long-term safety concerns. The use
of visible light in the red-yellow spectrum has the advantage of
deeper penetration into the skin (much more than UV light)
potentially treating deeper skin disease and thicker plaques and
lesions, similar to what was observed in the positive Phase 3 FLASH
(Fluorescent Light Activated Synthetic Hypericin) study in
CTCL. Synthetic hypericin or HyBryte™ (tradename used in
CTCL) was demonstrated in this study to be equally effective in
treating both plaque (42% treatment response rate after 12 weeks
treatment, p<0.0001 relative to placebo treatment) and patch
(37%, p=0.0009) lesions in this orphan disease caused by malignant
T-cells. In a published Phase 1/2 proof of concept clinical
study using synthetic hypericin, efficacy was demonstrated in
patients with CTCL (58.3% response, p=0.04) as well as psoriasis
(80% response, p<0.02).
This treatment approach avoids the risk of secondary
malignancies (including melanoma) inherent with both the frequently
used DNA-damaging drugs and other phototherapies that are dependent
on UV A or B exposure. The use of synthetic hypericin coupled
with safe, visible light also avoids the risk of serious infections
and cancer associated with the systemic immunosuppressive
treatments used in psoriasis.
About Psoriasis
Psoriasis is a chronic, non-communicable, itchy and often
painful inflammatory skin condition for which there is no
cure. Psoriasis has a significantly detrimental impact on
patients' quality of life, and is associated with cardiovascular,
arthritic, and metabolic diseases, as well as psychological
conditions such as anxiety, depression and suicide. Many
factors contribute to development of psoriasis including both
genetic and environmental factors (e.g., skin trauma, infections,
and medications). The lesions develop because of rapidly
proliferating skin cells, driven by autoimmune T-cell mediated
inflammation. Of the various types of psoriasis, plaque
psoriasis is the most common and is characterized by dry, red
raised plaques that are covered by silvery-white scales occurring
most commonly on the elbows, knees, scalp, and lower back.
Approximately 80% of patients have mild-to-moderate
disease. Mild psoriasis is generally characterized by the
involvement of less than 3% of the body surface area (BSA), while
moderate psoriasis will typically involve 3-10% BSA and severe
psoriasis greater than 10% BSA. Between 20% and 30% of
individuals with psoriasis will go on to develop chronic,
inflammatory arthritis (psoriatic arthritis) that can lead to joint
deformations and disability. Studies have also associated
psoriasis, and particularly severe psoriasis, with an increased
relative risk of lymphoma, particularly CTCL. Although
psoriasis can occur at any age, most patients present with the
condition before age 35.
Treatment of psoriasis is based on its severity at the time of
presentation with the goal of controlling symptoms. It varies
from topical options including PDT to reduce pain and itching, and
potentially reduce the inflammation driving plaque formation, to
systemic treatments for more severe disease. Most common
systemic treatments and even current topical photo/photodynamic
therapy such as UV A and B light, carry a risk of increased skin
cancer.
Psoriasis is the most common immune-mediated inflammatory skin
disease. According to the World Health Organization (WHO) Global
Report on Psoriasis 2016, the prevalence of psoriasis is between
1.5% and 5% in most developed countries, with some suggestions of
incidence increasing with time. It is estimated, based upon
review of historic published studies and reports and an
interpolation of data, that psoriasis affects 3% of the U.S.
population or more than 7.5 million people. Current estimates
have as many as 60-125 million people worldwide living with the
condition. The global psoriasis treatment market was valued
at approximately $15 billion in 2020
and is projected to reach as much as $40
billion by 2027.
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 proprietary
formulations of oral beclomethasone 17,21-dipropionate (BDP) for
the prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including 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
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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.
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.