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Soligenix Advances Phase 3 Study for HyBryte™, Targeting Cutaneous T-Cell Lymphoma

By Advos

TL;DR

Soligenix (NASDAQ: SNGX) advances phase 3 study for HyBryte(TM), a noninvasive therapy targeting malignant T-cells with precision.

HyBryte(TM) utilizes synthetic hypericin activated by visible light to treat early-stage cutaneous T-cell lymphoma with potential regulatory agency approval.

HyBryte(TM) offers a well-tolerated, innovative approach to tackle rare diseases, potentially improving treatment outcomes for patients worldwide.

Soligenix's HyBryte(TM) study introduces a game-changing therapy using safe visible light to target malignant T-cells effectively.

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Soligenix Advances Phase 3 Study for HyBryte™, Targeting Cutaneous T-Cell Lymphoma

Soligenix, a biopharmaceutical company, is advancing its phase 3 replication study for HyBryte™, a photodynamic therapy targeting early-stage cutaneous T-cell lymphoma (CTCL). The study, named FLASH2, builds upon the success of a previous phase 3 trial and aims to strengthen the case for this innovative treatment approach.

HyBryte™ represents a potentially significant advancement in CTCL treatment by utilizing synthetic hypericin activated by safe visible light. The therapy offers a noninvasive and well-tolerated alternative that precisely targets malignant T-cells, potentially addressing an unmet medical need for patients with this rare condition.

Patient enrollment is currently underway, with an interim analysis expected in early 2026. The study is strategically designed to meet regulatory requirements and potentially position HyBryte™ as a commercially available treatment option. This development underscores Soligenix's commitment to developing innovative therapies for challenging diseases.

The progress of HyBryte™ highlights the emerging potential of photodynamic therapy as a versatile medical approach. By demonstrating effectiveness in CTCL, the treatment could potentially be adapted for other dermatological and oncological conditions, representing a promising frontier in targeted medical interventions.

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