Soligenix Highlights Positive Clinical Results Published in Peer-Reviewed Dermatology Journal

Shares in late-stage biopharmaceutical company, Soligenix, Inc. (Nasdaq: SNGX), climbed more than 7.0% on Thursday morning after the company announced that the results of its compatibility study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) were published in the peer-reviewed Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice.

Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the compatibility study and Leading Enrolling Investigator in Soligenix’s FLASH study, said that the publication highlights the positive clinical results from the study.

“Being able to share the important results of this clinical trial with the world through publication in JEADV is a privilege and highlights the clinical significance of our work with HyBryte™. I have seen firsthand the promise this therapy can offer patients and was happy to build upon our knowledge working with HyBryte™ in a clinical setting reflective of real-world use.”

The JEADV published details of Soligenix’s open-label study, which enrolled nine patients to receive HyBryte™ treatment of their cancerous lesions over an eight-week period. Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. The treatment response results confirm the results of Soligenix’s Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial published in the Journal of the American Medical Association (JAMA) Dermatology.

“The ease at which photodynamic therapy with HyBryte™ is conducted and the outstanding safety profile we continue to see as demonstrated by the systemic exposure and cardiac results reviewed in this paper makes me very excited for its potential future clinical use,” said Dr. Poligone.

Soligenix expects to conduct a confirmatory placebo-controlled Phase 3 FLASH2 study in the second half of 2024.

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.

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Soligenix Highlights Positive Clinical Results Published in Peer-Reviewed Dermatology Journal

Catie Corcoran

Biotech Editor