Soligenix’s HyBryte™ Exceeds Safety and Efficacy of Standard of Care in 12-Week Treatment Study

Late-stage biopharmaceutical company, Soligenix, Inc (Nasdaq: SNGX), has announced positive clinical results from a 12-week study of its lead product candidate, HyBryte™ (synthetic hypericin), which has previously been evaluated in a successful Phase 3 FLASH clinical trial in the treatment of cutaneous T-cell lymphoma (CTCL). HyBryte™ demonstrated a more rapid and robust treatment response compared to Valchlor® (mechlorethamine gel) during a 12-week treatment course. HyBryte™ also demonstrated a more favorable safety profile than Valchlor®. 60% of Valchlor®-treated patients experienced adverse events related to the therapy including rashes, application site sensitivity or dermatitis requiring steroid treatment or study discontinuation. No such instances were reported in the HyBryte™ group.

The open-label study enrolled 10 patients (5 patients per group) with treatment success defined as a ≥50% improvement in a patient’s cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score after 12 weeks of topical treatment compared to Baseline. The study revealed that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus only 20% of Valchlor® patients.

“These results support the positive HyBryte™ data from the previously completed Phase 3 FLASH study and demonstrates that a relatively short treatment period with the drug can result in clinically meaningful outcomes,” said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.

Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study, commented, “Despite the small study sample size and a randomization that lead to the HyBryte™ group having patients with more extensive disease, HyBryte™ performed well and the results are consistent with previous studies demonstrating its rapid onset of action and benign safety profile compared to one of the most widely prescribed approved drugs for early-stage CTCL. The positive effect this therapy can have for patients and the outstanding safety profile that HyBryte™ continues to demonstrate is very encouraging. We look forward to continuing to support Soligenix and participating in the upcoming Phase 3 placebo-controlled study.”

Based on feedback from the European Medicines Agency (EMA), Soligenix expects to initiate a second, confirmatory Phase 3 study, called FLASH2, before the end of 2024. The company is in ongoing discussions with the FDA to agree on a development path that will adequately address the regulator’s feedback.

About Soligenix

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet’s Disease.

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.