Clinical Success Achieved in Second Cohort
of Patients
PRINCETON, N.J., Jan. 4, 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
preliminary top-line results of its ongoing Phase 2a trial of
SGX302 (synthetic hypericin) for the treatment of mild-to-moderate
psoriasis. In the expanded portion of the trial (Cohort 2), an
additional five patients were enrolled and the treatment guidelines
for use of light activation were adjusted to allow for a more rapid
escalation and higher final dose level of light than in the initial
cohort (Cohort 1) of patients, which is expected to more closely
mirror the way the drug will eventually be used in a "real world"
clinical setting.
The Cohort 2 patients were treated more aggressively than the
patients enrolled in Cohort 1 during an 18-week treatment period.
SGX302 therapy was well tolerated by all patients with no drug
related adverse events identified. In the four evaluable
patients from Cohort 2 (one patient withdrew early in the treatment
course for personal reasons unrelated to the study), two reached a
disease status of "Almost Clear" represented by an Investigator
Global Assessment (IGA) score of 1, which is considered the
standard clinical measure for treatment success in psoriasis. In
addition, the Psoriasis Activity and Severity Index (PASI) score,
another well-characterized measure of treatment success, for
patients in Cohort 2 had a mean drop of approximately 50% over the
18-week treatment.
"Having shown that topical synthetic hypericin has biologic
activity in patients with mild-to-moderate psoriasis in Cohort 1,
we are very pleased that, when the treatment is administered in a
similar manner that has proven successful with HyBryte™ in
cutaneous T-cell lymphoma (CTCL) patients, we also see evidence of
clinical success in patients with psoriasis," stated Richard Straube, MD, Chief Medical Officer and
Senior Vice President of Soligenix. "The ability of SGX302 to
produce clinically meaningful benefit for patients allows us to
further explore ways to optimize the therapy for this important and
difficult-to-treat chronic disease."
"We are pleased with the preliminary findings from our ongoing
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
continuing to pursue SGX302 in psoriasis as we complete discussions
with the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) regarding a feasible confirmatory trial
design for 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).
In an ongoing Phase 2a study in mild-to-moderate psoriasis,
patients enrolled in the initial portion of the trial (Part A) have
completed treatment. In Cohort 1, the initial five patients
enrolled received twice weekly treatment for 18 weeks with 0.25%
hypericin ointment, followed by light activation approximately 24
hours later. Light doses were increased by up to 1 J/cm2
on subsequent visits until mild erythema was observed in the
treated lesions. Light doses for all patients were still being
intermittently increased when the scheduled treatments ended, and
light doses were generally safe and well tolerated. Evaluation of
the initial cohort of five patients demonstrated a clear biological
signal, with the majority of patients recording an improvement in
the PASI score, providing evidence of biological improvement, but
no patient met the definition of treatment success (IGA score of 0
or 1) at the 18-week treatment timepoint. The second cohort of five
patients were enrolled once the Cohort 1 patients had completed all
treatment visits. Given how well-tolerated light treatments were in
the first Cohort, it was determined that the second cohort of
patients could safely receive an accelerated light treatment with
increases in the light dose by up to 2 J/cm2 at each
visit and allowing the maximum light dose (25 J/cm2) to
be reached earlier by approximately week 14, allowing more
treatments at the maximum light dose to be completed in the 18-week
treatment schedule. Two of the four evaluable patients from Cohort
2 achieved a clinical success score at some point during the
18-week treatment period and all evaluable patients improved,
yielding an average reduction of approximately 50% in the PASI
score. One patient in Cohort 2 dropped out of the study for
personal reasons unrelated to the study.
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 (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, Sudan 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, 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.
View original
content:https://www.prnewswire.com/news-releases/soligenix-announces-top-line-results-of-the-phase-2a-study-of-sgx302-synthetic-hypericin-in-patients-with-mild-to-moderate-psoriasis-302025994.html
SOURCE SOLIGENIX, INC.