Questions around this news
What evidence did the release cite for dusquetide in Behçet Disease?
The release points to supportive Phase 2a data that demonstrated biological efficacy and safety. It does not provide trial results, participant numbers, details of the treatment regimen, or a comparison with other treatments. The designation followed a positive recommendation from the European Medicines Agency.
What is Behçet Disease?
Behçet Disease is a rare, chronic inflammatory disorder that can affect blood vessels and multiple parts of the body. Common symptoms include recurring mouth sores, genital sores, and eye inflammation; some people also develop skin, joint, or other organ problems. Its course and symptoms vary from person to person.
What does a Phase 2a clinical trial assess?
A Phase 2a trial is an early clinical study that explores whether a treatment shows signs of activity for a particular condition. It may also gather information about safety and how the treatment is used. Its findings can inform later research, but they do not by themselves establish that a treatment is effective or approved.
Soligenix (NASDAQ: SNGX) announced the European Commission has granted orphan drug designation to dusquetide (SGX945) for the treatment of Behçet Disease, following a positive recommendation from the European Medicines Agency and supportive Phase 2a data demonstrating biological efficacy and safety. The designation provides up to 10 years of market exclusivity in the European Union and adds to existing FDA orphan and fast track designations, as the company advances its innate defense regulator platform targeting unmet needs in rare autoimmune conditions.
To view the full press release, visit https://ibn.fm/847sO
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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In brief
Soligenix says the European Commission has granted orphan drug designation to dusquetide, also identified as SGX945, for Behçet disease. The decision followed a positive recommendation from the European Medicines Agency and, according to the company, Phase 2a data showing biological efficacy and safety. Soligenix says the designation can provide up to 10 years of market exclusivity in the European Union. The company noted that dusquetide already has orphan and fast track designations from the U.S. Food and Drug Administration. The drug is part of Soligenix’s innate defense regulator platform, which the company is developing for rare autoimmune conditions and other inflammatory diseases.
Key takeaways
- The European Commission granted dusquetide orphan drug designation for Behçet disease.
- The decision followed a positive EMA recommendation and supportive Phase 2a data, according to Soligenix.
- The designation provides up to 10 years of EU market exclusivity.
- Soligenix says dusquetide also has FDA orphan and fast track designations.
SEC filings
Earlier from Soligenix
- Soligenix (NASDAQ: SNGX) Spotlighted in Recent Zacks Research Report as Key Clinical Milestones Approach
- Soligenix (NASDAQ: SNGX) HyBryte Data To Be Presented At USCLC Workshop Ahead Of AAD Meeting
- Soligenix (NASDAQ: SNGX) Strengthens Rare Disease Pipeline Program Through UK Regulatory Innovation Designation
- Soligenix (NASDAQ: SNGX) Highlights HyBryte Clinical Data in Peer-Reviewed Journal Publication
- Soligenix (NASDAQ: SNGX) SGX945 Granted Promising Innovative Medicine Designation in UK for Behçet Disease
