HyBryte™ has potential to address a
critical gap in treatment of early-stage CTCL
PRINCETON,
N.J., Dec. 1, 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 an article describing the potential use
of HyBryte™ in the treatment of cutaneous T-cell lymphoma
(CTCL) has been published in Frontiers in Drug Discovery.
The mini-review summarizes findings about the use, mechanism and
effectiveness of HyBryte™ in the treatment of CTCL with a
particular emphasis on the ability of HyBryte™ to address the unmet
medical need in patients with early-stage disease.
"With its chronic course and major impact on
patient quality of life, CTCL is an orphan disease in urgent need
of additional treatment options that are well-tolerated and safe
over the long term," stated Brian
Poligone, MD, PhD, Director of the Rochester Skin Lymphoma
Medical Group, Fairport, NY. "Clinical studies with HyBryte™
have demonstrated its safety and effectiveness, with broad
applicability across different lesion types, different skin tones
and different disease stages. I know I can speak for my colleagues
that have been involved with these studies when I say that the data
generated to date has been extremely compelling."
"In treating CTCL, which is a chronic cancer with
no cure, long-term safety is a strong driver of treatment choice.
Most current treatment options for CTCL are associated with
significant safety concerns, including black-box warnings. HyBryte™
treatment has demonstrated strong and rapid efficacy with a very
benign safety profile," stated Richard
Straube, MD, Senior Vice President and Chief Medical Officer
of Soligenix. "Studies to date have indicated a substantial
increase in efficacy with longer treatment with similar performance
against both patch and plaque lesions. These results are derived
from one of the largest studies ever conducted in CTCL and we
believe HyBryte™ will be of significant benefit to patients living
with this difficult disease."
About HyBryte™
HyBryte™ (research name SGX301) 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 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, 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 the first
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 groups also revealed a
statistically significant improvement (p<0.0001) between the two
groups, 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.
The Phase 3 CTCL clinical study was partially
funded by the National Cancer Institute via a Phase II SBIR grant
(#1R44CA210848-01A1) awarded to Soligenix, Inc. In addition, the
FDA awarded an Orphan Products Development grant to support the
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 approximate 700,000 individuals living with the
disease. 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 over 25,000 individuals in the U.S., with
approximately 3,000 new cases seen annually.
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.
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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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