Soligenix (NASDAQ: SNGX) has announced that the FDA has granted orphan drug designation to dusquetide—the active ingredient in SGX945—for the treatment of Behçet’s disease, upon review of Phase 2 trial results.
According to Soligenix, in addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions the company to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.
In a statement, Christopher J. Schaber, PhD, president and CEO of Soligenix, commented, “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 1 million people worldwide affected by this incurable disease. 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 auto-immune disease.”
Dr. Schaber concluded, “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.”
