Soligenix finishes patient enrollment for Phase 3 trial assessing HyBryte
Study Enrollment Completion: Soligenix has completed the enrollment of 50 patients for the interim analysis in its Phase 3 study evaluating HyBryte for treating cutaneous T-cell lymphoma (CTCL).
Study Design and Objectives: The confirmatory Phase 3 study, FLASH2, is a double-blind, placebo-controlled trial that aims to assess the efficacy of HyBryte over an extended 18-week treatment period, building on previous successful studies.
Interim Analysis Plan: The Data Monitoring Committee will conduct a formal interim analysis once approximately 60% of patients have completed the primary endpoint evaluation, mirroring the design of the initial FLASH study.
Expected Outcomes: The extended treatment duration is anticipated to provide a more statistically significant demonstration of HyBryte's effectiveness in a real-world treatment scenario, following a previous 49% treatment response rate observed in the first Phase 3 study.
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Soligenix Publishes Positive Phase 2a Results for SGX945 in Behçet's Disease Treatment
- Clinical Trial Results: Soligenix's SGX945 demonstrated significant improvement in 7 out of 8 patients in a Phase 2a trial for Behçet's Disease, indicating potential enduring effects after 4 weeks of treatment, which could enhance patient quality of life.
- Efficacy Comparison: After 4 weeks, the SGX945 group showed a 40% improvement relative to placebo, comparable to the 37% improvement seen with the approved drug apremilast, suggesting SGX945's competitive edge in the market.
- Patient Feedback: Patients reported reduced duration and number of oral ulcers during treatment, with SGX945 showing no treatment-related adverse events, indicating strong tolerability and potential for broader patient adoption.
- Future Development Plans: Soligenix intends to reformulate SGX945 for home-based treatment via subcutaneous injection, aiming to expand its application in innate immune-related inflammatory conditions, thereby enhancing its market competitiveness.
Soligenix Expands Psoriasis Trial, Revealing Improved Results with New Gel
Trial Results: Soligenix, Inc. announced extended results from its Phase 2a trial of SGX302 (synthetic hypericin) for mild-to-moderate psoriasis, showing improvements in various clinical measures with a new gel formulation that enhances application ease.
Patient Tolerance: The SGX302 gel therapy was well tolerated by all patients, with no drug-related adverse events reported, and one patient achieved a significant improvement in their psoriasis status.
Comparative Outcomes: The results from the gel formulation were comparable to or improved upon those from the previous ointment formulation, indicating effective treatment potential for psoriasis lesions.
Stock Performance: Following the announcement, Soligenix's stock experienced a decline of 21.05%, trading at $1.21.
