Soligenix updates US Medical Advisory Board for HyBryte clinical development.

Soligenix, a biopharmaceutical company, has updated its Medical Advisory Board for cutaneous T-cell lymphoma to provide guidance on advancing the Phase 3 clinical development of HyBryteTM for CTCL treatment. The board is comprised of dermatologic and oncologic thought leaders with extensive experience in CTCL.

Soligenix, Inc. (Nasdaq: SNGX), a biopharmaceutical company focused on developing and commercializing products to treat rare diseases, has recently updated its United States Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL). The update aims to provide strategic medical guidance as the company advances the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of CTCL, a rare class of non-Hodgkin's lymphoma (NHL).

The MAB, comprised of dermatologic and oncologic thought leaders with extensive experience in CTCL, has played a crucial role in the conduct of the ongoing FLASH2 Phase 3 clinical study. With recent retirements, the board has been updated to include additional key opinion leaders in CTCL, all of whom have participated in the HyBryte™ clinical program as principal investigators.

The updated MAB will continue to provide feedback, input, and guidance on the needs of the CTCL patient population, including clinical strategies and potential expansion into home-use applications. The board will also address health economics and reimbursement issues. Dr. Jennifer DeSimone, Dr. Youn Kim, Dr. Aaron Mangold, and Dr. Brian Poligone are among the esteemed members of the updated MAB.

HyBryte™, a novel photodynamic therapy utilizing safe, visible light for activation, has shown promising results in Phase 2 and 3 clinical studies. The active ingredient, synthetic hypericin, has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. The treatment approach avoids the risk of secondary malignancies inherent with DNA-damaging drugs and other phototherapies that are dependent on ultraviolet exposure.

The FLASH2 Phase 3 trial enrolled 169 patients with Stage IA, IB, or IIA CTCL. In the first treatment cycle, 16% of patients receiving HyBryte™ achieved at least a 50% reduction in their lesions compared to only 4% in the placebo group. In the second cycle, the response rate among the 12-week treatment group was 40%, significantly higher than the placebo treatment rate in Cycle 1. The third cycle focused on safety, with 66% of patients electing to continue treatment.

Overall, HyBryte™ has shown promising results in treating CTCL, with a significant improvement in response rates and safety profile. The company is excited to continue working with the updated MAB to advance HyBryte™ to commercialization worldwide.