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Phase 2a Study of Synthetic Hypericin for Mild to Moderate Psoriasis Yields Clinical Success

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Soligenix shared today positive top-line data stemming from the phase 2a clinical trial.

Nikkikii/Adobe Stock
Nikkikii/Adobe Stock

Soligenix Inc announced today positive top-line data stemming from its phase 2a study of SGX302 (synthetic hypericin), also known as HyBryte, in patients with mild to moderate psoriasis.

In this trial expansion (cohort 2), 5 additional participants amassing a total of 10 patients, were enrolled with a higher final dose of light and a more rapid escalation employed. This, Soligenix said, is more representative of its use in a real world clinical setting.

During the 18 weeks of more aggressive treatment, 2 of the 5 newly-enrolled patients (and of the 4 new patients who completed the trial) achieved an Investigator Global Assessment score of 1, indicative of "almost clear" skin clearance.

Additionally, patients in cohort 2 had an average 50% drop in Psoriasis Area and Severity Index scoring over the duration of the 18 weeks.

Therapy with synthetic hypericin was well-tolerated among patients, and no drug-related adverse events were identified by investigators.

During phase 1 of the study, synthetic hypericin demonstrated safety in a participant cohort. In the proof-of-concept phase, the treatment proved to be safe, effective, and well-tolerated, showcasing improvements in skin lesions among patients with psoriasis and cutaneous T-cell lymphoma (CTCL).

In July of last year, Soligenix announced it was expanding its trial of synthetic hypericin following the observation of a clear biological signal in the study's initial 5 participants.

Read more from Dermatology Times here.

"Having shown that topical synthetic hypericin has biologic activity in patients with mild-to-moderate psoriasis in Cohort 1, we are very pleased that, when the treatment is administered in a similar manner that has proven successful with HyBryte in cutaneous T-cell lymphoma patients, we also see evidence of clinical success in patients with psoriasis," said Richard Straube, MD, chief medical officer and senior vice president of Soligenix, in a press release.

"The ability of SGX302 to produce clinically meaningful benefit for patients allows us to further explore ways to optimize the therapy for this important and difficult-to-treat chronic disease," Straube said.

Reference

Soligenix Inc. Soligenix announces top-line results of the phase 2a study of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis. PR Newswire: press release distribution, targeting, monitoring and marketing. January 4, 2024. Accessed January 4, 2024. https://www.prnewswire.com/news-releases/soligenix-announces-top-line-results-of-the-phase-2a-study-of-sgx302-synthetic-hypericin-in-patients-with-mild-to-moderate-psoriasis-302025994.html#:~:text=Synthetic%20hypericin%20or%20HyBryte%E2%84%A2,caused%20by%20malignant%20T%2Dcells

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