synthetic hypericin (SGX302) / Soligenix - LARVOL DELTA

Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Soligenix | N=47 ➔ 15 | Recruiting ➔ Completed

Enrollment change • Trial completion • Dermatology • Immunology • Psoriasis

Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis (Soligenix Press Release) - "In this extension (Cohort 3) of the exploratory phase of the study, an additional four patients were enrolled and treated with an improved topical gel formulation of synthetic hypericin....On average over the three evaluable patients (one patient discontinued for personal reasons), there were improvements in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. One patient achieved a disease status of 'Almost Clear' using the IGA, which is considered a standard clinical measure for treatment success in psoriasis, with a substantial improvement in their PASI score, exceeding 50%."

P2a data • Trial status • Psoriasis

Soligenix Announces Recent Accomplishments… (PRNewswire) - "...'We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin)'..."

P2a data • Psoriasis

Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Soligenix | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Soligenix Announces Recent Accomplishments And First Quarter 2025 Financial Results (PRNewswire) - "Furthermore, we expect to report top-line results in the second half of this year from our ongoing Phase 2 studies of SGX945 (dusquetide) in Behçet's disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis..."

P2 data • Psoriasis

Soligenix Announces Recent Accomplishments and Year End 2024 Financial Results (PRNewswire) - "'In the second half of this year, we also anticipate reporting top-line results from our ongoing Phase 2 studies...SGX302 (synthetic hypericin) in mild-to-moderate psoriasis.'"

P2 data • Immunology • Psoriasis

HyBryte Treatment Studies Presented at…Medical Conferences in March (PRNewswire) - "Soligenix, Inc...announced today that its lead investigators...are presenting findings from recent supportive trials with...SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis. The presentations will occur at...the American Academy of Dermatology (AAD) Annual Meeting (March 7-11, 2025)."

P2 data • Immunology • Psoriasis

Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Soligenix | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Oct 2023 ➔ Apr 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Soligenix Announces Expansion of SGX302 (Synthetic Hypericin) Phase 2a Study in Mild-to-Moderate Psoriasis (Market Screener) - "Soligenix, Inc. announced the expansion of its Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in the initial five subjects. The study is expected to enroll at least an additional five subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study."

Trial status • Immunology • Psoriasis

Soligenix Receives USAN Approval for “Hypericin Sodium“ as Nonproprietary Name for Novel Active Ingredient in HyBryte and SGX302 (PRNewswire) - "Soligenix, Inc...announced today that the United States Adopted Names (USAN) Council has approved the use of the nonproprietary name of 'hypericin sodium' for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX302 for the treatment of mild-to-moderate psoriasis....'We look forward to continuing to work with the World Health Organization (WHO) to advance the International Nonproprietary Name (INN) hypericin from a proposed INN to a recommended INN, which is expected to occur later this year'."

Commercial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Psoriasis

Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Soligenix | Not yet recruiting ➔ Recruiting | N=32 ➔ 42

Enrollment change • Enrollment open • Dermatology • Immunology • Psoriasis

Topical SGX302 for Mild-to-Moderate Psoriasis (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Soligenix

New P2 trial • Dermatology • Immunology • Psoriasis

Soligenix Announces Recent Accomplishments And Third Quarter 2021 Financial Results (Yahoo Finance) - "Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022."

New P2a trial • Immunology • Psoriasis