Synthetic hypericin, the active ingredient in SGX301, is a photosensitizer that is meant to be applied to skin lesions, then activated by fluorescent light 16 to 24 hours later.
Hypericin was developed to treat cutaneous T-cell lymphoma (CTCL). Photo-activation prevents activated normal human lymphoid cells from proliferating and inhibits the growth of malignant T-cells.
Soligenix’s treatment approach avoids the risk of secondary malignancies, such as melanomas, which tend to occur when doctors prescribe a lot of chemotherapy and photodynamic therapies that rely on ultraviolet light.
Synthetic hypericin was shown to be an effective treatment for both CTCL and psoriasis in a Phase 2 clinical trial. Researchers found a statistically significant improvement in psoriasis patients with hypericin. Almost 56 percent got better, while no patients who took a placebo got better.
The research, “A phase II placebo-controlled study of photodynamic therapy with topical hypericin and visible light irradiation in the treatment of cutaneous T-cell lymphoma and psoriasis,” was published in the Journal of the American Academy of Dermatology.
“We are pleased to be granted additional protection for our intellectual property in Europe while we aggressively pursue SGX301 in CTCL. In the meantime, we are positioning synthetic hypericin for potential product expansion into other cutaneous T-cell diseases, such as psoriasis, as a component of our long-term strategy to enhance the value of our compound,” Christopher J. Schaber, PhD, president and chief executive officer of Soligenix, said in a press release. “With the promising Phase 2 results in both CTCL and psoriasis, we eagerly await the results of our ongoing Phase 3 CTCL clinical study, which are expected by the end of this year.”
Soligenix is now enrolling participants in a pivotal Phase 3 clinical trial (NCT02448381) to evaluate SGX301 as a treatment for CTCL.
SGX301 has received orphan drug status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of CTCL. Orphan drug status is given to treatments for rare diseases. The designation provides companies with financial and other incentives to continue developing the therapies.