September 21, 2021 at 11:23 am - by Editor Investors Prism
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.
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