Soligenix (NASDAQ: SNGX) announced that SGX945 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation by the U.K. Medicines and Healthcare Products Regulatory Agency for the treatment of Behcet's Disease. This designation marks the first step toward potential inclusion in the U.K.'s Early Access to Medicines Scheme (EAMS), which aims to provide patients with life-threatening or seriously debilitating conditions earlier access to promising therapies that are not yet approved.
The PIM designation was based on Phase 2 clinical data suggesting that dusquetide may offer 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 that can cause painful oral and genital ulcers, skin lesions, arthritis, and potentially severe ocular and neurological complications. Current treatment options are limited and often associated with significant side effects.
According to Soligenix, the PIM designation underscores the potential of dusquetide to address an unmet medical need. Dusquetide is a first-in-class innate defense regulator (IDR) that modulates the body's immune response to inflammation without suppressing the immune system. The company is also developing dusquetide (SGX942) for oral mucositis in head and neck cancer patients.
The EAMS scheme, managed by the MHRA, allows for the use of unlicensed medicines in patients with high unmet need. Receipt of PIM designation is a prerequisite for applying for an EAMS scientific opinion, which, if granted, would enable clinicians to prescribe dusquetide to eligible patients in the U.K. before it receives marketing authorization.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical needs. Its specialized biotherapeutics segment includes HyBryte (SGX301) for cutaneous T-cell lymphoma, SGX302 for psoriasis, and dusquetide for inflammatory diseases. The company's public health solutions segment includes vaccines against ricin toxin, filoviruses, and COVID-19, utilizing its ThermoVax heat stabilization platform.
For more information on Soligenix and its pipeline, visit the company's newsroom at https://ibn.fm/SNGX. Disclaimers and terms of use are available at http://IBN.fm/Disclaimer.
