Two Presentations Highlight Data
Demonstrating Hypericin Photodynamic Therapy Potential with a
Preliminary Comparison to Current Therapy
PRINCETON, N.J., March 6,
2025 /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 lead investigators for the cutaneous T-cell lymphoma
(CTCL) and psoriasis programs are presenting findings from recent
supportive trials with HyBryte™ (synthetic hypericin) in the
treatment of CTCL and SGX302 (synthetic hypericin) in the treatment
of mild-to-moderate psoriasis. The presentations will occur at the
United States Cutaneous Lymphoma Consortium (USCLC) Workshop
(March 6, 2025) and the American
Academy of Dermatology (AAD) Annual Meeting (March 7-11, 2025). Ellen
Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice
Chair of Clinical Operations, Dermatology Department, and Professor
of Dermatology at the Hospital of the University of Pennsylvania, and who was the
Principal Investigator for the first Phase 3 FLASH (Fluorescent
Light Activated Synthetic Hypericin) study, will present a poster
at the USCLC detailing recent results from an ongoing
investigator-initiated study using HyBryte™ as a long-term
treatment of CTCL. Neal Bhatia, MD,
FAAD, Director of Clinical Dermatology at Therapeutics Clinical
Research and Principal Investigator of Study HPN-PSR-01, and who
participated in the FLASH study, will present at the AAD and
discuss general considerations on the use of topical and
photodynamic therapy, including synthetic hypericin.
Presentations:
Conference: USCLC Workshop "Cutaneous
Lymphomas in Special Populations" March
6, Orlando,
Florida. The official conference program can be
found here.
Presentation Title: Topical hypericin ointment photodynamic
therapy for early stage mycosis fungoides/CTCL – a Phase 2 real
world investigator-initiated study presented by Dr.
Ellen Kim, Director, Penn Cutaneous
Lymphoma Program, Vice Chair of Clinical Operations, Dermatology
Department, and Professor of Dermatology at the Hospital of the
University of Pennsylvania.
Conference: AAD Annual Meeting,
March 7-11, Orlando, Florida
Presentation
Title: What's new this year in Topical therapy?
presented by Dr. Neal Bhatia,
Director of Clinical Dermatology at Therapeutics Clinical Research
and chief medical editor at Practical Dermatology. The official
conference program can be found here.
These presentations incorporate the Company's findings in
recent supportive studies which have demonstrated the utility
of longer treatment times (Study RW-HPN-MF-01;
investigator-initiated study), the lack of significant systemic
exposure to hypericin after topical application (Study
HPN-CTCL-02) and its relative efficacy and tolerability compared to
Valchlor® (Study HPN-CTCL-04).
About the USCLC Workshop
The United States Cutaneous Lymphoma Consortium is a
multidisciplinary society of physicians which use collaborative
research and education to improve the quality of life and prognosis
of patients with cutaneous lymphoma. This workshop is held annually
to facilitate collaboration. The meeting website is available
here.
About the AAD Annual Meeting
The American Academy of Dermatology Association Annual Meeting
is one of the largest dermatologic scientific meetings globally and
is attended by both researchers and dermatologists. The meeting
website is available here.
About HyBryte™ / Synthetic Hypericin
HyBryte™ (research name SGX301 in CTCL, SGX302 in psoriasis) is
a novel, first-in-class, photodynamic therapy utilizing safe,
visible light for activation. The active ingredient in HyBryte™ is
synthetic hypericin, a potent photosensitizer that is topically
applied to skin lesions that is taken up by the malignant T-cells,
and then activated by safe, visible light approximately 24 hours
later. The use of visible light in the red-yellow spectrum has the
advantage of penetrating more deeply into the skin (much more so
than ultraviolet light) and therefore potentially treating deeper
skin disease and thicker plaques and lesions. This treatment
approach avoids the risk of secondary malignancies (including
melanoma) inherent with the frequently employed DNA-damaging drugs
and other phototherapy that are dependent on ultraviolet exposure.
Combined with photoactivation, hypericin has demonstrated
significant anti-proliferative effects on activated normal human
lymphoid cells and inhibited growth of malignant T-cells isolated
from CTCL patients. In a published Phase 2 clinical study in CTCL,
patients experienced a statistically significant (p=0.04)
improvement with topical hypericin treatment whereas the placebo
was ineffective. HyBryte™ has received orphan drug and fast track
designations from the FDA, as well as orphan designation from the
European Medicines Agency (EMA).
The published Phase 3 FLASH trial enrolled a total of 169
patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial
consisted of three treatment cycles. Treatments were administered
twice weekly for the first 6 weeks and treatment response was
determined at the end of the 8th week of each cycle. In the first
double-blind treatment cycle (Cycle 1), 116 patients received
HyBryte™ treatment (0.25% synthetic hypericin) and 50 received
placebo treatment of their index lesions. A total of 16% of the
patients receiving HyBryte™ achieved at least a 50% reduction in
their lesions (graded using a standard measurement of dermatologic
lesions, the CAILS score) compared to only 4% of patients in the
placebo group at 8 weeks (p=0.04) during the first treatment cycle
(primary endpoint). HyBryte™ treatment in this cycle was safe and
well tolerated.
In the second open-label treatment cycle (Cycle 2), all patients
received HyBryte™ treatment of their index lesions. Evaluation of
155 patients in this cycle (110 receiving 12 weeks of HyBryte™
treatment and 45 receiving 6 weeks of placebo treatment followed by
6 weeks of HyBryte™ treatment), demonstrated that the response rate
among the 12-week treatment group was 40% (p<0.0001 vs the
placebo treatment rate in Cycle 1). Comparison of the 12-week and
6-week treatment responses also revealed a statistically
significant improvement (p<0.0001) between the two timepoints,
indicating that continued treatment results in better outcomes.
HyBryte™ continued to be safe and well tolerated. Additional
analyses also indicated that HyBryte™ is equally effective in
treating both plaque (response 42%, p<0.0001 relative to placebo
treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to
placebo treatment in Cycle 1) lesions of CTCL, a particularly
relevant finding given the historical difficulty in treating plaque
lesions in particular.
The third (optional) treatment cycle (Cycle 3) was focused on
safety and all patients could elect to receive HyBryte™ treatment
of all their lesions. Of note, 66% of patients elected to continue
with this optional compassionate use / safety cycle of the study.
Of the subset of patients that received HyBryte™ throughout all 3
cycles of treatment, 49% of them demonstrated a positive treatment
response (p<0.0001 vs patients receiving placebo in Cycle 1).
Moreover, in a subset of patients evaluated in this cycle, it was
demonstrated that HyBryte™ is not systemically available,
consistent with the general safety of this topical product observed
to date. At the end of Cycle 3, HyBryte™ continued to be well
tolerated despite extended and increased use of the product to
treat multiple lesions.
Overall safety of HyBryte™ is a critical attribute of this
treatment and was monitored throughout the three treatment cycles
(Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™
mechanism of action is not associated with DNA damage, making it a
safer alternative than currently available therapies, all of which
are associated with significant, and sometimes fatal, side effects.
Predominantly these include the risk of melanoma and other
malignancies, as well as the risk of significant skin damage and
premature skin aging. Currently available treatments are only
approved in the context of previous treatment failure with other
modalities and there is no approved front-line therapy available.
Within this landscape, treatment of CTCL is strongly motivated by
the safety risk of each product. HyBryte™ potentially represents
the safest available efficacious treatment for CTCL. With very
limited systemic absorption, a compound that is not mutagenic and a
light source that is not carcinogenic, there is no evidence to date
of any potential safety issues.
Following the first Phase 3 study of HyBryte™ for the treatment
of CTCL, the FDA and the EMA indicated that they would require a
second successful Phase 3 trial to support marketing approval. With
agreement from the EMA on the key design components, the second,
confirmatory study, called FLASH2, the Company initiated enrollment
in December 2024. This study is a
randomized, double-blind, placebo-controlled, multicenter study
that will enroll approximately 80 subjects with early-stage CTCL.
The FLASH2 study replicates the double-blind, placebo-controlled
design used in the first successful Phase 3 FLASH study that
consisted of three 6-week treatment cycles (18 weeks total), with
the primary efficacy assessment occurring at the end of the initial
6-week double-blind, placebo-controlled treatment cycle (Cycle 1).
However, this second study extends the double-blind,
placebo-controlled assessment to 18 weeks of continuous
treatment (no "between-Cycle" treatment breaks) with the primary
endpoint assessment occurring at the end of the 18-week timepoint.
In the first Phase 3 study, a treatment response of 49%
(p<0.0001 vs patients receiving placebo in Cycle 1) was observed
in patients completing 18 weeks (3 cycles) of therapy. In this
second study, all important clinical study design components remain
the same as in the first FLASH study, including the primary
endpoint and key inclusion-exclusion criteria. The extended
treatment for a continuous 18 weeks in a single cycle is expected
to statistically demonstrate HyBryte's™ increased effect over a
more prolonged, "real world" treatment course. Given the extensive
engagement with the CTCL community, the esteemed Medical Advisory
Board and the previous trial experience with this disease,
accelerated enrollment in support of this study is anticipated,
including the potential to enroll previously identified and treated
HyBryte™ patients from the FLASH study. Discussions with the FDA on
an appropriate study design remain ongoing. While collaborative,
the agency has expressed a preference for a longer duration
comparative study over a placebo-controlled trial. Given the
shorter time to potential commercial revenue and the similar trial
design to the first FLASH study afforded by the EMA accepted
protocol, this study has begun enrolling patients. At the same
time, discussions with the FDA will continue on potential
modifications to the development path to adequately address their
feedback.
Additional supportive studies have demonstrated the utility
of longer treatment times (Study RW-HPN-MF-01), the lack of
significant systemic exposure to hypericin after topical
application (Study HPN-CTCL-02) and its relative efficacy and
tolerability compared to Valchlor® (Study
HPN-CTCL-04).
In addition, the FDA awarded an Orphan Products Development
grant to support the investigator-initiated study evaluation of
HyBryte™ for expanded treatment in patients with early-stage CTCL,
including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the
University of Pennsylvania that was a
leading enroller in the Phase 3 FLASH study.
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of
cancer of the white blood cells that are an integral part of the
immune system. Unlike most NHLs which generally involve B-cell
lymphocytes (involved in producing antibodies), CTCL is caused by
an expansion of malignant T-cell lymphocytes (involved in
cell-mediated immunity) normally programmed to migrate to the skin.
These malignant cells migrate to the skin where they form various
lesions, typically beginning as patches and may progress to raised
plaques and tumors. Mortality is related to the stage of CTCL, with
median survival generally ranging from about 12 years in the early
stages to only 2.5 years when the disease has advanced. There is
currently no cure for CTCL. Typically, CTCL lesions are treated and
regress but usually return either in the same part of the body or
in new areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of
the more than 1.7 million individuals living with the disease in
the U.S. and Europe (European
Union and United Kingdom). It is
estimated, based upon review of historic published studies and
reports and an interpolation of data on the incidence of CTCL that
it affects approximately 31,000 individuals in the U.S. (based on
SEER data, with approximately 3,200 new cases seen annually) and
approximately 38,000 individuals in Europe (based on ECIS prevalence estimates,
with approximately 3,800 new cases annually).
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 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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