SNGX Soligenix Inc

PCG Digital -- Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company, is making significant strides in the treatment of Cutaneous T-Cell Lymphoma (CTCL) with its investigational drug, HyBryte™. In an exclusive interview, PCG Digital speaks with Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for Soligenix’s comparative study, who shares insights on the promising advancements.

Key Highlights from the Interview:

• Need for Rapid and Safe Treatments: Given that CTCL is incurable but manageable with chronic treatment, there is a critical need for therapies that can induce rapid remission and be safely used over long periods.
• Comparative Study Findings: Dr. Poligone discusses the HPN-CTCL-04 study, which compared HyBryte™ to Valchlor®. Preliminary results indicate that HyBryte™ is both safe and effective. The study used standard CTCL measurements to compare the safety and efficacy of these two therapies. Initial findings suggest that HyBryte™ was safe and effective relative to the FDA-approved, gold-standard Valchlor®. Dr. Poligone noted, “Valchlor® is one of our most commonly used drugs in the clinic. It's a topical chemotherapy applied once daily, and some patients will react to it, experiencing an allergy or reaction that makes it intolerable. Additionally, some patients do not respond to it, even after extended use. Due to these issues and others, Valchlor® is not the only drug we need. We need alternative treatments for those cases."
• Patient Experience and Clinician Feedback: The Phase 3 FLASH study, published in JAMA Dermatology, showed that HyBryte™ provides a quick response and is well-tolerated by patients. Higher doses used in subsequent studies were also well-received, with adverse events comparable to or better than those in previous studies. Dr. Poligone remarked, “From my standpoint as a clinician who sees patients with this lymphoma every day, they're eager to get this drug. They're excited about what they're hearing, and since it's been available in my clinic, they have been asking for it, which I think is a good sign. Similarly, among my colleagues treating lymphoma patients, there is a lot of eagerness to know when this will be approved and available outside of a clinical trial setting.”
• Safety Profile: The recent HPN-CTCL-02 examined the safety characteristics of HyBryte™ while extending observations of its effect in CTCL. Very low doses of HyBryte™ were found in the blood after application to large body surface areas, with no effects on the heart, liver, kidneys, or bone marrow. These findings will be presented at the upcoming EORTC CTCL meeting in Switzerland this October.
• Future Trials: Dr. Poligone also shared his optimism about the upcoming confirmatory Phase 3 FLASH2 trial, which will build on the strong data from previous studies. Recruitment for FLASH2 will be driven by the positive safety and efficacy data, making it easier to enroll both new and previous patients eager to access HyBryte™.

Soligenix plans to initiate patient enrollment in the confirmatory FLASH 2 study with HyBryte™ by the end of 2024. The company continues to explore the potential of HyBryte™ in treating other dermatological conditions such as psoriasis, where it has a Phase 2 study ongoing, demonstrating its commitment to expanding treatment options for patients with skin diseases.

For the full interview, watch the video here: https://youtu.be/R8khcNmj9ZQ?si=fXPpQrgPhTJVL1Hx

Read the latest interview with Dr. Ellen Kim on Soligenix’s promising Phase 3 FLASH trial here: https://prismmarketview.com/soligenixs-hybryte-lighting-the-way-towards-commercial-success-with-promising-flash-study-results/

About SoligenixSoligenix 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).

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A video accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/2e857033-bd5f-49ed-bbe1-ef6adf88a6a6