Soligenix Expands Synthetic Hypericin Psoriasis Study

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Additional patients will be enrolled in the phase 2a study after a clear biological signal was demonstrated in initial participants.

Biopharmaceutical company Soligenix Inc has announced1 the expansion of its phase 2a psoriasis trial following promising initial observations, namely a demonstrated biological effect, in the study’s initial 5 participants.

fusssergei/AdobeStock
fusssergei/AdobeStock

The trial2 is examining the use of SGX302 (synthetic hypericin) in patients with mild-to-moderate cases of psoriasis. SGX302 is a form of photodynamic light therapy that uses the photoactive compound hypericin in the form of an ointment coupled with visible fluorescent light. Visible light-activated synthetic hypericin is a first-in-class therapy and potent photosensitizer.

Soligenix describes SGX302 as a safe treatment option enabling patients to receive more frequent treatments with fewer risks and toxicities, given fewer risks of cancer with fluorescent light when compared to UV A or UV B light.

In phase 1 of the study, synthetic hypericin was safe in a cohort of participants. In a proof of concept phase of the study, it was safe, effective, and well-tolerated in improving skin lesions among patients with psoriasis and cutaneous T-cell lymphoma (CTCL).

"Patients with mild-to-moderate disease do not qualify for the use of biologics and have fewer treatment options. The patients enrolled in this study all demonstrated clinical improvement and, with the experience gained in this first portion of the study, we anticipate being able to further improve responses as we move forward," said Neal Bhatia, MD, in the press release from Soligenix.1

Bhatia is the director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and chair of Soligenix’s psoriasis medical advisory board.

"Having previously participated in the positive Phase 3 clinical trial of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma, I have had a clinical interest in this novel therapy and am pleased that the Soligenix team is advancing synthetic hypericin in psoriasis where there remains an unmet medical need,” Bhatia said. “Similar to CTCL, psoriasis is a chronic disease where the management of side effects and toxicities is as important as the management of the disease itself. Psoriasis affects more than 7.5 million patients in the U.S. alone, and 60-125 million people worldwide. Having treated psoriasis patients for over 20 years and seen first-hand how they struggle to find good treatment options, access to an additional effective and safe therapy would add significantly to patient care and quality of life for many people that are living with this disease."

Synthetic hypericin currently has Fast Track designation for treating CTCL in the United States. It also has orphan drug designation in the US for both CTCL and T-cell lymphoma and solely for CTCL in Europe. The United Kingdom Medicines and Healthcare products Regulatory Agency has also given synthetic hypericin the Promising Innovative Medicine designation for CTCL treatment.

References

  1. Soligenix Inc. Soligenix announces expansion of SGX302 (synthetic hypericin) phase 2a study in mild-to-moderate psoriasis. PR Newswire: press release distribution, targeting, monitoring and marketing. July 11, 2023. Accessed July 11, 2023. https://www.prnewswire.com/news-releases/soligenix-announces-expansion-of-sgx302-synthetic-hypericin-phase-2a-study-in-mild-to-moderate-psoriasis-301873900.html.
  2. SGX302, plaque psoriasis treatment for mild to moderate psoriasis. Soligenix. February 3, 2023. Accessed July 11, 2023. https://www.soligenix.com/pipeline-programs/sgx302-for-mild-to-moderate-psoriasis/.
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