- Soligenix’s HyBryte(TM) is a photodynamic therapy using synthetically manufactured hypericin, one of the most photoactive compounds available.
- The therapeutic potential of HyBryte(TM) has been demonstrated through multiple clinical trials, including a Phase 3 trial in early-stage CTCL patients.
- HyBryte(TM) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
Cutaneous T-cell lymphoma (“CTCL”) is a rare and debilitating form of non-Hodgkin’s lymphoma that primarily affects the skin, posing both physical and emotional challenges for those diagnosed. With limited treatment options available and no definitive cure, the need for innovative, safe and effective therapies is urgent. Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company, is focused on developing and commercializing products to treat rare diseases. At the forefront of Soligenix’s pipeline is HyBryte(TM), a novel therapy aimed at treating early-stage CTCL.
CTCL affects the skin by causing malignant T-cells to accumulate in the upper layers, often resulting in patches, plaques and tumors that can be intensely itchy, painful, and disfiguring. The disease can significantly impair quality of life and, in more advanced stages, may involve other parts of the body such as the lymph nodes, blood and internal organs.
According to the Cutaneous Lymphoma Foundation, approximately 3,000 new cases of CTCL are diagnosed in the United States each year, with an estimated 30,000 to 40,000 individuals living with the disease nationwide (https://nnw.fm/gZbWY). While CTCL tends to progress slowly, it is chronic and currently incurable, requiring ongoing treatment to manage symptoms and improve patients’ quality of life.
This chronic nature makes the search for better treatment solutions even more critical, especially as existing therapies often involve systemic immunosuppressants, phototherapy or chemotherapy, which can carry serious side effects and limit long-term effectiveness. The need for treatments that are not only effective but also safe and tolerable over long durations is pressing.
Soligenix’s HyBryte(TM) (synthetic hypericin) is a photodynamic therapy using synthetically manufactured hypericin, which is one of the most photoactive compounds available (https://nnw.fm/OdDhR). Used in ointment or gel form, synthetic hypericin is combined with visible fluorescent or LED light. Because it is easily activated with relatively low-energy light, HyBryte(TM) is ideal for photodynamic therapy because it can be activated with safe visible light instead of damaging UVA or UVB light, which are associated with increased cancer risks.
This mechanism is particularly significant in treating CTCL, a condition that often requires repeated and prolonged skin treatments. HyBryte(TM) offers a noninvasive alternative that may reduce the cumulative toxicity and side effects often seen with current options.
The therapeutic potential of HyBryte(TM) has been demonstrated in multiple clinical trials, including a Phase 3 trial in early-stage CTCL patients. The company recently released interim results from the ongoing open-label, investigator-initiated study (“IIS”) evaluating extended HyBryte(TM) treatment for up to 54 weeks in patients with early-stage CTCL (https://nnw.fm/f4lwr). Following 18 weeks of treatment, 75% of patients achieved “treatment success,” reinforcing HyBryte(TM) as a potentially safe and fast-acting therapy for this chronic and underserved cancer.
In January 2025, Soligenix announced expanded access treatment results that also showed positive outcomes, reinforcing the drug’s safety and efficacy profile in real-world applications (https://nnw.fm/PtUYO). Patients who continued treatment beyond the original trial timeline maintained or improved their clinical responses, a particularly encouraging outcome in the management of a disease known for its relapsing and remitting course.
HyBryte(TM) has also been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”), which provides regulatory incentives including market exclusivity, tax credits for clinical testing, and exemption from user fees. This designation not only underscores the drug’s potential to address an unmet medical need but also enhances its commercial viability, if approved. Furthermore, Soligenix has expressed intentions to pursue marketing approval worldwide, including the European Union, where HyBryte(TM) has also received Orphan Drug Designation from the European Medicines Agency (“EMA”), which could pave the way for broader access to the treatment and significant benefits for patients globally.
In addition, Soligenix is engaging with the broader medical and scientific communities to ensure HyBryte’s(TM) integration into treatment protocols, should regulatory approval be granted. As the company continues to build on its clinical successes, its commitment to innovation in rare disease treatment remains clear. The development of HyBryte(TM) for CTCL reflects Soligenix’s broader mission: to deliver novel treatment solutions for underserved patient populations. With the increasing prevalence of CTCL and the limited scope of current treatment options, HyBryte(TM) could represent a much-needed breakthrough in how the disease is managed, offering new hope to thousands of individuals living with this complex and chronic lymphoma.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://nnw.fm/SNGX
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