Soligenix (NASDAQ: SNGX) Visible Light Therapeutic Addresses Large, Underserved Markets
HyBryte™ provides a safe treatment alternative for the over 30,000 Americans with cutaneous T cell lymphoma (CTCL)
Soligenix is advancing towards NDA filing and U.S. commercialization of HyBryte™ in the treatment of CTCL
Company to expand treatment to other cutaneous T cell diseases, including psoriasis, which affects up to 125 million people worldwide
Soligenix, a biopharmaceutical company specializing in treatments for rare diseases, has developed a safe, effective fluorescent light therapy that will help the nearly 30,000 Americans who are newly diagnosed or living with of cutaneous T cell lymphoma each year.
More than 20,000 Americans are currently living with the disease, which is commonly treated with photodynamic (PDT) therapy that exposes the skin to harmful ultraviolet A and B wavelengths. HyBryte™, by Soligenix, offers a safe and effective alternative to existing first-line treatment.
- HyBryte is a synthetic hypericin ointment that can be combined with fluorescent light to treat early-stage CTCL
- Treatment uses safe, visible light, allowing patients to avoid the short and long-term side effects of DNA-damaging UV light
- The HyBryte study was a multi-center randomized, controlled blinded trial held in the US
- 169 patients were enrolled in the study which consisted of three cycles, each six weeks long, with two treatments per week, and a two week rest period before results were measured
- Efficacy results from the Phase 3 trial showed that 49% of patients receiving 3 cycles of HyBryte responded to treatment.
- The HyBryte response rate is comparable to other skin-directed therapies studied and the safety profile was excellent, with responses seen in both patch and deeper plaque lesions
Psoriasis is a chronic inflammatory skin disease affecting over eight million Americans and 125 million people around the world. The global market for psoriasis drugs is anticipated to reach as much as $40 billion by 2027.
Soligenix has demonstrated positive proof-of-concept of synthetic hypericin in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients and will be expanding this novel therapy in psoriasis with a Phase 2a clinical study. Patient enrollment is expected to begin in the second half of 2022.
The company has a strong cash position and does not anticipate needing to raise additional capital to support this Phase 2a trial.