Soligenix (NASDAQ: SNGX) announced that SGX945 (dusquetide) has received Promising Innovative Medicine (PIM) designation from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of Behcet's Disease. This designation represents the first step toward potential inclusion in the U.K.'s Early Access to Medicines Scheme (EAMS), which allows patients with life-threatening or seriously debilitating conditions to access promising therapies earlier than through standard regulatory pathways.
The PIM designation was granted based on Phase 2 clinical data indicating that dusquetide may provide a significant advantage over existing treatments while demonstrating a favorable potential benefit-risk profile for patients with this rare inflammatory disorder. Behcet's Disease is a chronic, relapsing systemic vasculitis characterized by oral and genital ulcers, skin lesions, and ocular inflammation, with no curative treatments currently available.
Dusquetide is a first-in-class innate defense regulator (IDR) technology developed by Soligenix. It modulates the body's innate immune response to reduce inflammation and promote resolution of tissue damage. The drug has previously shown promise in other inflammatory conditions, including oral mucositis in head and neck cancer patients. The PIM designation underscores the potential of dusquetide to address unmet medical needs in Behcet's Disease.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical needs. Their Specialized BioTherapeutics business segment is also advancing HyBryte (SGX301) for cutaneous T-cell lymphoma and expanding synthetic hypericin (SGX302) into psoriasis. The company's Public Health Solutions segment includes vaccine programs against ricin, filoviruses, and COVID-19, utilizing their proprietary ThermoVax heat stabilization platform.
The full press release is available at https://ibn.fm/N8oN5. For more information and updates on Soligenix, visit their newsroom at https://ibn.fm/SNGX.
Forward-looking statements in this article involve risks and uncertainties as detailed in Soligenix's SEC filings. Undue reliance should not be placed on forward-looking statements, which are based on information available as of the date hereof.
