FAQ on Soligenix Inc.'s FDA Orphan Drug Designation for Dusquetide in Behçet’s Disease
Summary
Soligenix Inc. has been granted FDA orphan drug designation for dusquetide, the active ingredient in SGX945, for treating Behçet’s Disease, following promising Phase 2a clinical results.
What is the significance of the FDA orphan drug designation for Soligenix Inc.?
The FDA orphan drug designation is significant as it provides Soligenix Inc. with certain benefits, including market exclusivity upon approval, tax credits for clinical testing, and waiver of certain FDA fees, to develop dusquetide for treating Behçet’s Disease, a rare condition.
What is dusquetide and what is its intended use?
Dusquetide is the active ingredient in SGX945, developed by Soligenix Inc., intended for the treatment of Behçet’s Disease, a rare inflammatory disorder, as well as other inflammatory diseases.
How does the orphan drug designation impact patients with Behçet’s Disease?
The orphan drug designation accelerates the development and review process for dusquetide, potentially bringing a new treatment option to patients with Behçet’s Disease sooner.
What are the next steps for Soligenix Inc. following this designation?
Following the orphan drug designation, Soligenix Inc. will continue to advance the development of dusquetide, including further clinical trials, towards seeking regulatory approvals for its use in treating Behçet’s Disease.
Where can I find more information about Soligenix Inc. and its developments?
More information about Soligenix Inc. and its developments can be found in the company’s newsroom at https://ibn.fm/SNGX.
What other diseases is Soligenix Inc. targeting with its pipeline?
Soligenix Inc. is also targeting cutaneous T-cell lymphoma (CTCL) with HyBryte™, psoriasis with SGX302, inflammatory diseases including oral mucositis with SGX942, and has vaccine programs for ricin toxin, filoviruses, and COVID-19.
How does Soligenix Inc. fund its research and development?
Soligenix Inc. funds its research and development through government grants and contracts from entities like the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).
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