Soligenix, Inc. reports developments as a late-stage biopharmaceutical company focused on rare diseases and public health medical countermeasures. Company news centers on HyBryte (synthetic hypericin), a visible-light activated therapy program for cutaneous T-cell lymphoma, and SGX945 (dusquetide) for Behçet's Disease, including clinical data, published study results and regulatory designations.
Updates also cover the Public Health Solutions segment, including RiVax ricin toxin vaccine candidate, filovirus vaccine programs, CiVax for COVID-19 and the ThermoVax heat-stabilization platform. Recurring announcements include operating and financial results, government-supported development activities, material agreements, shareholder voting matters and governance updates.
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Soligenix has submitted a Type A Meeting Request to the FDA for discussions on a second Phase 3 study of HyBryte™ (SGX301) for treating cutaneous T-cell lymphoma (CTCL). This follows significant success in the initial Phase 3 FLASH trial, where 16% of patients treated with HyBryte™ showed at least a 50% reduction in lesions compared to 4% for the placebo (p=0.04). The FDA has classified the meeting as high priority, expected within approximately 30 days. HyBryte™ utilizes synthetic hypericin and visible light, posing a safer alternative to conventional treatments by avoiding DNA damage. The company anticipates alignment with the FDA on a pivotal study design to expedite further development of this promising treatment.