Soligenix, Inc. (NASDAQ:SNGX) stock is higher on Monday after the U.S. Food and Drug Administration granted orphan drug designation to dusquetide, the active ingredient in SGX945, for Behçet’s Disease.
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The update follows the review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease.
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for rare diseases and disorders.
In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix 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 (NDA), and certain tax credits.
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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 are affected by Behçet’s Disease, a rare inflammatory disorder that can affect various parts of the body, most notably causing painful sores in the mouth and genitals, along with eye inflammation.
Preclinical efficacy and safety have been demonstrated in numerous animal disease models, including mucositis, colitis, macrophage activation syndrome, as well as bacterial infections.
In addition, potential anti-tumor activity has been demonstrated in multiple in vitro and in vivo xenograft studies.
Dusquetide has demonstrated safety and tolerability in a Phase 1 study in 84 healthy human volunteers. In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits.
Dusquetide has also demonstrated biological efficacy and safety in a Phase 2a pilot study in eight patients with Behçet’s Disease.
SNGX Price Action: Solignenix stock is up 67.29% at $4.65 at publication on Monday.
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