Soligenix Inc. (NASDAQ: SNGX) Announces Positive Phase 2 Data for Rare Inflammatory Disease

• Behçet’s disease is characterized by unpredictable flare-ups and periods of remission, making long-term management particularly challenging.
• Current treatment strategies for the disease focus on controlling inflammation and suppressing immune activity using corticosteroids, immunosuppressants and biologic agents.
• Soligenix has released positive top-line results from its phase 2 clinical trial evaluating SGX945 for the treatment of aphthous ulcers associated with Behçet’s.

Behçet’s disease is a rare, chronic inflammatory condition that can cause recurrent, painful ulcers, eye inflammation and systemic complications that significantly affect quality of life. Because available treatments are limited and often inconsistent, clinical trial updates in this disease area carry particular importance. Soligenix (NASDAQ: SNGX) is reporting results from a phase 2a proof of concept study evaluating its investigational therapy, SGX945 (dusquetide), for the treatment of Behçet’s disease, representing a notable step forward in efforts to improve care for patients with this underserved condition.

Behçet’s disease is classified as a variable vessel vasculitis, meaning it can affect blood vessels of all sizes throughout the body. The disease is characterized by unpredictable flare-ups and periods of remission, making long-term management particularly challenging. According to the National Organization for Rare Disorders, Behçet’s disease commonly presents with recurrent oral ulcers in nearly all patients and can progress to involve the genitals, skin, eyes, joints, gastrointestinal tract and central nervous system, potentially leading to permanent disability or vision loss in severe cases. The complexity of the disease and its multisystem involvement contribute to delays in diagnosis and inconsistent treatment outcomes.

Globally, Behçet’s disease is considered rare, but prevalence varies widely by geography, with higher incidence reported in regions along the historic Silk Road, including parts of the Middle East, East Asia and the Mediterranean. In the United States and Europe, prevalence estimates are significantly lower, often averaging 5.2 cases per 100,000 people, according to the National Institutes of Health. Despite its rarity, the disease burden is substantial because it typically affects individuals in early adulthood, disrupting education, employment and long-term productivity.

Current treatment strategies for Behçet’s disease focus on controlling inflammation and suppressing immune activity using corticosteroids, immunosuppressants and biologic agents. While these therapies can reduce symptoms, they are often associated with systemic side effects, increased infection risk and variable efficacy across patient populations. There remains a significant need for targeted therapies that can effectively control disease manifestations while minimizing long-term toxicity. This unmet clinical need underscores the importance of continued therapeutic innovation in this space.

Soligenix addresses this unmet need through the release of positive top-line results from its phase 2a clinical trial evaluating SGX945, also known as dusquetide, for the treatment of aphthous ulcers associated with Behçet’s disease. The results highlight improvements in ulcer resolution and pain reduction. According to the company, patients treated with SGX945 experienced faster healing and fewer days with active ulcers, outcomes that directly address one of the most debilitating aspects of the disease.

SGX945 is a novel innate defense regulator designed to modulate the body’s immune response rather than broadly suppress it. Soligenix explains that this mechanism aims to reduce harmful inflammation while preserving the immune system’s ability to fight infection, a critical distinction from many existing immunosuppressive therapies. In the phase 2 study, SGX945 was reported to be safe and well tolerated, an important consideration for a chronic disease requiring repeated or long-term treatment.

The phase 2a trial was an open-label study designed to be highly comparable (e.g., study endpoints, inclusion-exclusion criteria) to the published Phase 3 study that was used to support marketing approval of apremilast (Otezla(R)) for oral ulcers in Behçet’s disease.. Soligenix reported that the study met its key endpoints, including reductions in ulcer duration and associated pain. These outcomes are clinically meaningful, as recurrent oral ulcers are a hallmark symptom of Behçet’s disease and a major driver of patient discomfort and reduced quality of life.

Beyond the immediate results, the phase 2 data provide important validation of SGX945’s therapeutic approach and support further clinical development. Soligenix has indicated that these findings will support discussions with regulatory authorities regarding the design a follow-on clinical study. The company’s broader pipeline focuses on rare diseases with high unmet medical need, leveraging immune-modulating technologies to address conditions where conventional therapies fall short.

For patients with Behçet’s disease, the announcement represents incremental but meaningful progress in a field where treatment innovation has historically lagged. While additional studies are planned to confirm efficacy and durability of response, the phase 2 results suggest that SGX945 could offer a targeted, well-tolerated option for managing the disease’s most burdensome symptoms. As research continues, advances such as these highlight the potential for immune-modulating therapies to reshape care for rare inflammatory disorders.

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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