Phase 2a clinical study of SGX945 in
Behçet's Disease initiating in 2024
PRINCETON, N.J., Feb. 8, 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 the
formation of a Medical Advisory Board (MAB) to provide
medical/clinical strategic guidance to the Company as it advances
the clinical development of SGX945 (dusquetide) for the treatment
of Behçet's Disease. The Company previously announced that the U.S.
Food and Drug Administration (FDA) had granted Fast Track
designation for dusquetide in the treatment of oral lesions of
Behçet's Disease.
"I am honored to have such a prestigious and dedicated group of
physicians committed to working with us as we develop dusquetide
therapy for Behçet's Disease," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "We have assembled some of the
world's leading experts in this field who collectively have
hundreds of publications and have the experience of treating
thousands of patients with this chronic condition. The initiation
of a Phase 2a clinical study in Behçet's Disease later this
year will be another important milestone for our company and we
look forward to working with the MAB to advance this program."
Comprised of internationally renowned rheumatologists with
extensive experience in Behçet's Disease, the MAB will play an
important advisory role in the conduct of the upcoming Phase 2a
clinical study, as well as in the design of subsequent clinical
studies and associated regulatory interactions with health
authorities. The MAB will provide feedback, input and guidance on
clinical strategies and their implementation, as well as on other
critical items, such as health economics and reimbursement, to
assist Soligenix in meeting the needs of patients suffering from
Behçet's Disease.
The MAB Members
Gülen Hatemi, MD
Dr. Hatemi is one of the world's leading physicians in the
treatment of Behçet's Disease and leads the largest Behçet's
research center in the world at Istanbul University –
Cerrahpaşa, Behçet's Disease Research Center. Dr. Hatemi has
over 250 publications in her field and has conducted numerous
clinical research trials to understand the life impact of Behçet's
syndrome, to develop management strategies, and to improve outcome
measures for clinical trials of Behçet's Disease. Dr. Hatemi is the
convener of the Disease Assessment Study Group of the International
Society for Behçet's Disease and co-chair of the OMERACT (Outcome
Measures in Rheumatology) Behçet's syndrome working group where she
focuses on developing outcome measures for clinical trials and
improving outcomes for patients with Behçet's Disease. She is also
a member of the European Union of Medical Specialists Section of
Rheumatology. Dr. Hatemi completed rheumatology training in
Istanbul University,
Cerrahpaşa Medical School, Department of Internal Medicine,
after completing residencies in both Internal Medicine and
Pulmonary Medicine at Instanbul University. She received her
medical degree from Cerrahpaşa Medical School.
Johannes Nowatzky, MD
Dr. Johannes Nowatzky is the Saul J. Farber Associate Professor
of Medicine and Pathology at New York
University (NYU) Grossman School
of Medicine, where he directs the NYU Behçet's Disease Center. Dr.
Nowatzky has extensive experience in Behçet's Disease, seeing
thousands of patients, and sits on the Medical Advisory Board for
the American Behçet's Disease Foundation. Clinically trained in the
Middle East, Europe, and the U.S., he has unique expertise
with Behçet's Disease from large referral centers in these regions.
Dr. Nowatzky is a physician-scientist who, in addition to running
the most extensive clinical Behçet's Disease program in the U.S.,
directs an immunology research laboratory focused on the biology of
Behçet's Disease and ocular inflammation. His numerous publications
in the field include primary research in impactful
immunology/rheumatology journals, such as Annals of the Rheumatic
Diseases. Dr. Nowatzky completed his fellowship at NYU Langone
Medical Center and his residency in Internal Medicine at Hadassah
Medical School, Israel. He
received his medical degree from the Faculty of Medicine, Freie
University Berlin, Germany.
Andrew Sulich,
MD
Dr. Sulich is a rheumatologist in private practice at Shores
Rheumatology, St. Clair Shores,
MI, and Chief of Rheumatology at Ascension Saint John
Medical Center in Detroit. He is
also Assistant Clinical Professor at the William Beaumont
Oakland University School of Medicine,
and a clinical instructor of rheumatology for the residency
programs at Saint John Hospital and Medical Center in the Beaumont
Hospital System. Dr. Sulich has been honored with multiple awards,
including Hour magazine "Top Docs" for 2010 to 2020. Dr. Sulich is
a fellow of the American College of Rheumatology and is a member of
organizations such as the American College of Physicians, the
Michigan State Medical Society, the Arthritis Foundation and a
member of the Medical Advisory Board for the American Behçet's
Foundation. Dr. Sulich completed his internship at Mount Carmel
Mercy Hospital in Detroit. He
completed his residency at St. John Hospital and Medical Center,
where he served as chief resident. His rheumatology fellowship was
completed at Henry Ford Hospital and he received his medical degree
from the American University of the
Caribbean School of Medicine in Saint Maarten.
Yusuf Yazici,
MD
Dr. Yazici is an internationally renowned rheumatologist,
researcher and expert in clinical trial design and management. He
is a Clinical Associate Professor at NYU. His areas of interest are Behçet's Disease,
osteoarthritis, rheumatoid arthritis, early arthritis, patient
reported outcomes, database and registry management and monitoring
of arthritis patients in regard to clinical response and adverse
events related to treatment. He has published more than 250 medical
papers and book chapters and has given numerous national and
international presentations. Dr. Yazici has been Chief Medical
Officer of Biosplice Therapeutics, Inc. since 2013, leading the
development of new therapies for osteoarthritis, various oncologic
conditions and Alzheimer's disease, and sits on the Medical
Advisory Board for the American Bechet's Disease Foundation. Dr.
Yazici completed his fellowship in rheumatology at the Hospital for
Special Surgery and Weill Medical College of
Cornell University, New York
City, NY and his residency in internal medicine at
Creighton University, Omaha, NE. Dr. Yazici received his medical
degree from Istanbul University,
Istanbul, Turkey.
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 bacterial Gram-negative and Gram-positive 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 80,000 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, 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) as a novel photodynamic therapy utilizing safe visible
light for the treatment of cutaneous T-cell lymphoma (CTCL).
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 for the treatment of inflammatory diseases, including
oral mucositis in head and neck cancer (SGX942) and in Behçet's
Disease (SGX945). 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,"
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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.
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SOURCE SOLIGENIX, INC.