- The FDA’s orphan drug designation for dusquetide follows encouraging phase 2a clinical trial results demonstrating both biological efficacy and a favorable safety profile.
- CEO notes that “the FDA’s decision to grant orphan drug designation to the SGX945 program signifies an important step for Soligenix.”
- Phase 2a pilot data demonstrated clinically meaningful improvements in oral aphthous ulcer healing.
Soligenix (NASDAQ: SNGX) has taken a decisive step forward in the fight against rare diseases, announcing that the FDA has granted orphan drug designation to its investigational therapy dusquetide for the treatment of Behçet’s disease (https://ibn.fm/0t1aK). This key FDA designation underscores not only the strength of recent phase 2 results but also the company’s growing reputation as a late-stage biopharmaceutical innovator dedicated to tackling serious, underserved conditions.
The FDA’s orphan drug designation for dusquetide follows encouraging phase 2a clinical trial results demonstrating both biological efficacy in reducing oral aphthous ulcers and a favorable safety profile in patients with Behçet’s disease (https://ibn.fm/idr7M). The designation not only highlights the promise of Soligenix’s SGX945 program but also unlocks critical development incentives, such as seven years of U.S. market exclusivity upon approval, potential government grant support, fee waivers and valuable tax credits.
“Behçet’s disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 in Europe, 350,000 people in Turkey and as many as one million people worldwide affected by this incurable disease,” said Soligenix CEO Dr. Christopher J. Schaber. “Given the clinically meaningful improvements seen in a 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 autoimmune disease. The FDA’s decision to grant orphan drug designation to the SGX945 program 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.”
Characterized by painful redness, swelling and ulceration of the mucous membranes in the mouth, oral mucositis is a common and debilitating condition often triggered by chemotherapy, radiotherapy or hematopoietic stem cell transplantation. The condition causes severe pain, disrupts oral intake and can lead to infections or require nutritional interventions such as parenteral feeding. In extreme cases, treatment protocols may be interrupted or dosage reduced, negatively impacting patient outcomes. Because it compromises patients’ ability to speak, eat and swallow, oral mucositis significantly diminishes quality of life and poses serious challenges in the management of cancer and other treatments.
Soligenix’s development work with dusquetide, specifically targeting oral ulcers, taps into the broader medical need to address oral mucositis effectively. The company’s SGX945 (dusquetide) has earned both fast-track and orphan drug designations for its role in treating oral lesions in Behçet’s disease, further emphasizing the potential overlap with mucositis management Dusquetide belongs to a class of innate defense regulators (“IDRs”) that modulate the immune response to promote healing, reduce inflammation and protect tissues, an approach that may have meaningful implications for alleviating painful mouth ulcers in Behçet’s patients and possibly beyond.
Phase 2a pilot data demonstrated clinically meaningful improvements in oral aphthous ulcer healing, with SGX945 proving well-tolerated and showing no significant adverse effects, a notable contrast to current treatments such as apremilast, known for common side effects such as headache, nausea and diarrhea. This emerging evidence underscores Soligenix’s potential to address a critical unmet need and improve patient outcomes in an underserved population.
By combining regulatory incentives, clinical traction and a compelling therapeutic strategy, Soligenix is establishing a solid development pathway for SGX945. The orphan designation strengthens the company’s IP position and paves the way for future clinical development. As Soligenix advances its SGX945 program, it reinforces its overarching mission to develop novel treatments for rare and challenging conditions, including its ongoing progress with its ricin toxin vaccine candidate (https://ibn.fm/g2Hkx), moving the company closer to delivering impactful therapies to patients in need.
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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