Soligenix Inc. (NASDAQ: SNGX) Makes Advancement in Proprietary Treatment for Behçet’s Disease

• Behçet’s disease is more prevalent in countries along the Silk Road, including Türkiye, Iran and Japan.
• Even with treatment, symptoms can continue occurring for many patients and significantly affect their quality of life and productivity.
• Soligenix has initiated a clinical trial to evaluate the safety, tolerability and preliminary efficacy of SGX945 in patients suffering from oral ulcers.

Behçet’s disease is a rare, chronic autoimmune disorder characterized by inflammation of blood vessels, leading to a range of symptoms including painful mouth and genital ulcers, eye inflammation and skin lesions. With limited treatment options available, Soligenix (NASDAQ: SNGX) is at the forefront of developing innovative therapies, notably SGX945 (dusquetide), aiming to address the unmet need in this challenging disease landscape (https://ibn.fm/KByRu).

Behçet’s disease is rare, with prevalence estimates varying from 0.12 to 7.5 per 100,000 in the United States and Europe. It’s more prevalent in countries along the Silk Road, including Türkiye, Iran, and Japan. In Türkiye, prevalence can range from 80 to 370 per 100,000. Symptoms of the disease include mouth sores, eye irritation and swelling, skin rashes and sores, and genital sores (https://ibn.fm/Hxv0M).

Behçet’s disease is believed to be an autoimmune illness with both genetic and environmental components. Symptoms are most severe in young adulthood and generally ameliorate with age. While the aphthous ulcers of Behçet’s disease are extremely painful, they are not usually associated with long-term damage, although scarring is a prevalent concern. More rarely, Behçet’s disease can affect other organ systems, such as the eyes, lungs, and brain, and may even become life threatening. 

Treatment involves medications designed to ease symptoms and prevent serious complications, such as blindness. Even with treatment, oral and genital flares can continue to occur for many patients and significantly affect quality of life and productivity. In addition, treatments can be associated with adverse effects, underscoring the need for more targeted and effective therapies.

Soligenix is addressing this therapeutic gap through the development of SGX945, an investigational drug designed to modulate the body’s innate immune response. SGX945 is a synthetic peptide that enhances the resolution of inflammation and promotes tissue healing without suppressing the immune system. Preclinical studies have demonstrated its potential in reducing inflammation and accelerating healing in various models.

Soligenix has initiated a phase 2a clinical trial to evaluate the safety, tolerability and preliminary efficacy of SGX945 in patients with Behçet’s disease suffering from oral ulcers (https://ibn.fm/krror). This small, open-label, proof-of-concept study is enrolling patients at a single center in Türkiye. The efficacy endpoint focuses on the reduction in the number and duration of oral ulcers, while secondary efficacy endpoints include assessments of pain reduction and overall disease activity. The trial’s design reflects a comprehensive approach to understanding SGX945’s therapeutic potential in this patient population.

Soligenix’s commitment to advancing SGX945 aligns with its broader mission to develop and commercialize products that address unmet medical needs in rare diseases. The company’s pipeline includes a range of product candidates targeting inflammatory conditions and biodefense indications. SGX945’s development represents a significant step toward providing a novel, non-immunosuppressive treatment option for patients with Behçet’s disease, potentially improving quality of life and disease management.

As the phase 2a trial progresses, the medical community remains attentive to the outcomes, which could herald a new era in the treatment of Behçet’s disease. Soligenix’s innovative approach exemplifies the potential of targeted therapies in addressing complex autoimmune conditions, offering hope to patients and clinicians seeking more effective and safer treatment alternatives.

For more information, visit www.Soligenix.com.

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX

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