In brief
Soligenix says its candidate SGX945, also known as dusquetide, has received Promising Innovative Medicine designation from the U.K. Medicines and Healthcare Products Regulatory Agency for Behçet’s disease. The designation is an initial step toward possible entry into the U.K.’s Early Access to Medicines Scheme, which can provide earlier access to therapies for people with life-threatening or seriously debilitating conditions. The company says Phase 2 clinical findings supported the designation, suggesting the candidate may offer an advantage over existing treatments and a favorable potential benefit-risk profile. PIM status does not itself establish inclusion in the access scheme. Soligenix is a biopharmaceutical company developing treatments for rare diseases.
Key takeaways
- SGX945 received PIM designation in the U.K. for Behçet’s disease.
- The designation is an initial step toward possible inclusion in the U.K.’s Early Access to Medicines Scheme.
- Soligenix says Phase 2 data supported the designation and indicated potential benefits compared with existing treatments.
Soligenix (NASDAQ: SNGX) announced that SGX945 (dusquetide) has received Promising Innovative Medicine (“PIM”) designation from the U.K. Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet’s Disease. The designation represents the first step toward potential inclusion in the U.K.’s Early Access to Medicines Scheme, which allows patients with life-threatening or seriously debilitating conditions to access promising therapies earlier. 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.
To view the full press release, visit https://ibn.fm/N8oN5
About Soligenix
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behcet’s Disease.
Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grant and contract funding from 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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Questions around this news
What does PIM designation mean for SGX945?
The U.K. Medicines and Healthcare Products Regulatory Agency granted SGX945 Promising Innovative Medicine designation for Behçet’s disease. According to the release, PIM is the first step toward possible inclusion in the Early Access to Medicines Scheme; it is not described as an approval or as a guarantee of access through that scheme.
What evidence supported the PIM designation?
The release says the designation was based on Phase 2 clinical data indicating that dusquetide may offer a significant advantage over existing treatments and may have a favorable potential benefit-risk profile for people with Behçet’s disease. It does not provide specific trial results or describe the comparison in further detail.
What is Behçet’s disease?
Behçet’s disease is a rare inflammatory disorder that can affect blood vessels and multiple parts of the body. It often involves recurring mouth sores and may also cause genital sores, eye inflammation, skin problems, or joint symptoms. Its course and severity can vary among individuals.
