Clinical Trials
Soligenix has specialized clinical trial expertise
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances (Orphan Drug designation, Fast Track designation, use of adaptive trial designs etc.) and clinical execution (specialized recruitment approaches, direct site interactions etc.). Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in personal contact with the sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets.
Actively Enrolling Patients
FLASH2 Clinical Study: Fluorescent Light Activated Synthetic Hypericin 2
Soligenix is conducting a confirmatory, randomized, placebo-controlled Phase 3 study evaluating HyBryte™ as a treatment for early-stage cutaneous T-cell lymphoma.
A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Synthetic Hypericin) and Visible Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).
The purpose of this study is to evaluate the use of HyBryte™ for 18 continuous weeks when compared to placebo. HyBryte™ contains the active pharmaceutical ingredient, synthetic hypericin, which is a novel topical photosensitizing agent, to treat patients with early-stage cutaneous T-cell lymphoma (mycosis fungoides). Approximately 80 patients will be randomized into this study with enrollment ongoing.
Learn more about this trial on ClinicalTrials.gov (NCT06470451).
Actively Enrolling Patients
SGX945 for Aphthous Ulcers of Behçet’s Disease
Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet’s Disease
This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behçet’s Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks. This study is actively enrolling.
Learn more about this trial on ClinicalTrials.gov (NCT06386744).
Actively Enrolling Patients
Topical SGX302 for Mild-to-Moderate Psoriasis
Phase 2a Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis
The purpose of this study is to evaluate SGX302 (topical synthetic hypericin ointment or gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis. Patient enrollment is ongoing.
Learn more about this trial on ClinicalTrials.gov (NCT05442190).
Actively Enrolling Patients
HyBryte™ Expanded Treatment Trial
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Lights
This study is an open-label, multicenter clinical trial enrolling approximately 20 patients. Patients have the potential to be treated for up to 12 months with twice a week dosing (visible light activation following ointment application by 24 ± 6 hours). The study also allows for potential transition to a “real-world” setting with home-use. The primary endpoint for the study is evaluating the number of treatment successes defined as ≥50% reduction in the cumulative mCAILS score from Baseline to end of the treatment.
The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award by the U.S. Food and Drug Administration (FDA).
Learn more about this trial on ClinicalTrials.gov (NCT05872854).