Improving Patient Quality Of Life: Soligenix Progresses Treatment For Painful Ulcers Associated With Rare Behcet's Disease
Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases and areas of unmet medical need, is utilizing its pharmaceutical expertise to treat Behcet's disease, an autoimmune condition mainly associated with inflammation of the blood vessels and the eyes, though the inflammation of the blood vessels often causes many different issues throughout the body.
Behcet's Disease Explained
Behcet's disease, or Silk Road disease, is a non-curable long-term condition caused by blood vessel inflammation. This inflammation affects and damages both the arteries and veins. Primarily diagnosed in young adults, its effects and severity will vary over time. Indications of the disease within individuals usually include mouth sores, skin rashes and lesions, genital sores, leg ulcers and eye inflammation, with inflammation of the joints observed in the most severe cases. It is a painful disease that directly impacts the patient's quality of life and ability to engage in life activities, including working productively.
Demographically, as its alternate name suggests, the disease is most common along the 'Silk Road' in the Middle East and East Asia, including Turkey, Iran, Japan and China. It is less prevalent in the U.S. but can develop at any age, equally affecting both men and women.
Behcet's Disease Addressable Market
According to estimates compiled by Soligenix, as many as 1,000,000 people worldwide live with Behcet's Disease, with approximately 18,000 known cases in the U.S. and 80,000 in Europe. As reported by BioSpace, the market for Behcet's disease is estimated to reach $184.5 million by 2035; it is currently valued at $105.1 million (2024). The market growth is attributed to the adoption of advanced, minimally invasive treatment options such as biologic therapies, monoclonal antibodies and targeted immunomodulators. These treatments effectively address underlying inflammation and systemic symptoms while reducing side effects and long-term reliance on corticosteroids, such as prednisone. Current therapies suppress inflammation and immune function.
Soligenix's Treatment Of Behcet's Disease
Soligenix's drug candidate for treating Behcet's disease is SGX945. Dusquetide, the active ingredient in SGX945, 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, they can increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. Dusquetide also accelerates the resolution of tissue damage following exposure to a variety of agents, including bacterial pathogens, trauma and chemo- and/or radiation therapy.
SGX945's treatment is administered as a 4-minute IV infusion twice a week. It is intended for use to enhance the resolution of oral, genital and skin ulcer flares in Behçet's Disease.
In 2024, Soligenix announced the phase 2 clinical trial of SGX945 in treating Behcet's Disease. The clinical trial will be an open-label study that will enroll approximately 25 patients aged 18 years or older with mild to moderate Behcet's Disease and active oral and/or genital ulcers. Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for 4 weeks, followed by 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance and patient-reported quality of life assessments. Regarding the launch of the clinical study, Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, stated, 'We are pleased to have received FDA clearance and Turkish Medicines and Medical Devices Agency (Turkey's Ministry of Health) authorization to start patient enrollment into our SGX945 Phase 2a pilot trial in aphthous ulcers of Behcet's Disease. Our previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. Given the role of the innate immune system in ulcers associated with Behcet's Disease, and the unmet medical need particularly for more severe ulcers such as genital and leg ulcers, we believe that dusquetide may offer significant relief to patients. We are excited to expand dusquetide's development into different innate immune-related inflammatory conditions, such as Behcet's Disease, as a component of our long-term strategy to enhance the value of this unique compound.'
Looking Ahead
The launch of the phase 2 clinical trial of SGX945 is a milestone moment for Soligenix. As the firm progresses in treating Behcet's Disease and other rare diseases, it is looking to establish a distinct value proposition in the market that cannot be easily replicated or counter-positioned against.
As the firm continues on its product development initiatives, new opportunities for sustainable growth may emerge over time, potentially strengthening its market position.
Featured photo by Lucas Vasques on Unsplash.
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