Soligenix Inc. (NASDAQ: SNGX) Secures Key European Milestone for Dusquetide Development

• “The EMA’s positive opinion signifies an important step for Soligenix as we continue to advance the program,” says company CEO.
• The designation provides incentives that may include protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following approval.
• Dusquetide is classified as an innate defense regulator, a type of compound designed to modulate the body’s innate immune system rather than suppress it outright.

For patients living with rare inflammatory diseases, regulatory milestones can mark the difference between stalled research and meaningful therapeutic progress. A positive opinion from the European Medicines Agency (EMA) not only validates a drug’s scientific rationale but can also unlock development incentives that accelerate its path forward. In that context, Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing treatments for rare diseases and areas of unmet medical need, announced that it has received a positive opinion from the EMA’s Committee for Orphan Medicinal Products for its pipeline product dusquetide in the treatment of Behcet’s disease.

“We are extremely pleased to have received the positive opinion from the COMP and look forward to the European Commission granting the orphan drug designation for the SGX945 program,” said Soligenix CEO and president Christopher J. Schaber, PhD. Behçet’s disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 people in Europe, 350,000 people in Türkiye and as many as 1 million people worldwide affected by this incurable disease.

“Given the clinically meaningful improvements seen in our phase 2 proof-of-concept study in patients with oral aphthous ulcers due to Behçet’s disease, we are hopeful dusquetide will have a role to play in helping underserved patients suffering from this difficult to treat and chronic auto-immune disease,” Schaber continued. “The EMA’s positive opinion signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing intellectual property estate surrounding this novel technology.”

In the European Union, orphan medicinal product designation is granted to therapies intended to treat life-threatening or chronically debilitating conditions affecting no more than five in 10,000 people, according to the European Commission. The designation provides incentives that may include protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following approval, as outlined by the European Medicines Agency. These benefits are designed to encourage companies to invest in treatments for rare diseases that might otherwise lack sufficient commercial incentive.

Behcet’s disease is a rare, chronic, multisystem inflammatory disorder characterized by recurrent oral and genital ulcers, skin lesions and, in some cases, inflammation affecting the eyes, joints, blood vessels and nervous system. The National Library of Medicine describes Behcet’s as a complex autoimmune-related condition that can lead to serious complications, including vision loss when ocular inflammation is severe. While the disease is more common along the historic Silk Road regions such as Türkiye and parts of the Middle East and East Asia, it remains rare in Europe and North America, supporting its qualification for orphan designation under EU criteria.

There is currently no cure for Behcet’s disease. Treatment generally focuses on reducing inflammation and managing symptoms through corticosteroids, immunosuppressive medications and biologic agents. Because the disease can relapse unpredictably and may require long-term immunosuppressive therapy, patients often face ongoing risks associated with chronic immune modulation. This underscores the importance of developing novel approaches that aim to regulate immune responses more precisely rather than broadly suppress them.

Soligenix’s investigational therapy for Behcet’s disease is dusquetide, the active pharmaceutical ingredient in SGX945. According to the company, dusquetide is classified as an innate defense regulator, a type of compound designed to modulate the body’s innate immune system rather than suppress it outright. Dusquetide targets the p62/sequestosome-1 signaling pathway, which plays a role in regulating inflammation and immune responses. By modulating this pathway, dusquetide is intended to reduce inflammatory damage while preserving normal immune defense mechanisms.

Soligenix has previously evaluated dusquetide in other inflammatory settings. The company reports that dusquetide has been studied in clinical trials for oral mucositis and other immune-related conditions, providing clinical experience with the molecule’s safety and mechanism of action. The rationale for its use in Behcet’s disease stems from its potential ability to rebalance dysregulated immune responses that drive ulcer formation and systemic inflammation.

The positive opinion from the Committee for Orphan Medicinal Products does not itself constitute marketing approval, but it is a critical regulatory milestone. Following a positive opinion, the European Commission often issues a formal decision on orphan designation. If granted, the designation may provide Soligenix with development incentives and regulatory support that could facilitate further clinical advancement.

For patients living with Behcet’s disease, the potential availability of a new therapeutic option that aims to regulate immune response rather than broadly suppress it could represent a meaningful advancement. Chronic inflammation and recurrent ulcerations can significantly impair quality of life, and current therapies may not fully control disease activity or may carry long-term safety considerations. The advancement of dusquetide under an orphan designation framework signals continued momentum in rare disease research.

As Soligenix moves forward, the European Medicines Agency’s positive opinion provides both validation and strategic leverage. In rare-disease drug development, regulatory alignment and incentive programs can make a substantial difference in the feasibility of bringing new treatments to market. For Soligenix, this milestone reinforces its commitment to addressing rare inflammatory disorders and strengthens the foundation for continued development of dusquetide in Behcet’s disease.

For more information, visit www.Soligenix.com.

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