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Soligenix Expands Phase 2a Study of SGX302 for Mild-to-Moderate Psoriasis Treatment

Wednesday, July 12, 2023

Soligenix, a biopharmaceutical company traded on Nasdaq under the ticker symbol SNGX, has recently announced the expansion of its Phase 2a trial for SGX302, a synthetic hypericin compound. This trial focuses on evaluating SGX302 as a potential treatment for mild-to-moderate psoriasis, a chronic skin condition with limited treatment options.

The decision to expand the trial came after promising results were observed in the initial five subjects. These patients demonstrated a clear biological response to the treatment, with improvements recorded in the psoriasis area and severity index (PASI) scores. To further investigate the efficacy of SGX302, the study will enroll at least five additional subjects, who will receive the treatment in combination with standard care for psoriasis.

Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research and Chair of Soligenix's Psoriasis MAB, expressed optimism about the study's progress. He emphasized that patients with mild-to-moderate psoriasis often face limited options for effective treatment, and the expansion of this trial could lead to improved outcomes and better management of the disease.

Soligenix aims to explore the potential of SGX302 in addressing unmet medical needs beyond orphan indications. Psoriasis affects a significant number of individuals worldwide, with estimates ranging from 60 to 125 million people. The global market for psoriasis treatment was valued at approximately $15 billion in 2020 and is projected to reach $40 billion by 2027.

Dr. Christopher J. Schaber, President and CEO of Soligenix, expressed satisfaction with the initial trial results. He highlighted the success of another synthetic hypericin product, HyBryte™, in targeting malignant T-cells in the treatment of cutaneous T-cell lymphoma (CTCL). This success serves as a promising indicator of the potential of SGX302 to provide an effective approach for treating mild-to-moderate psoriasis, which also involves dysregulated T-cells.

Soligenix plans to provide additional data from the SGX302 study before the end of the year. The company is also engaged in discussions with the FDA regarding the design of a Phase 3 trial for HyBryte™ in the treatment of early-stage CTCL. These developments reflect Soligenix's commitment to advancing innovative therapies and addressing critical medical needs in various disease indications.

Synthetic hypericin is an innovative photodynamic therapy (PDT) being explored for the treatment of psoriasis. Unlike other PDT treatments, synthetic hypericin is activated by visible light, which reduces the long-term risks associated with alternative PDT therapies. This potent photosensitizer is topically applied to skin lesions and absorbed by cutaneous T-cells. Upon activation by safe, visible light, it induces apoptosis in T-cells, addressing the underlying cause of psoriasis lesions. Unlike some other PDTs that use ultraviolet (UV) light, which can raise concerns about safety, the use of visible light in the red-yellow spectrum allows for deeper penetration into the skin, potentially treating more extensive and deeper skin disease.

Promising results were observed in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study, which evaluated the effectiveness of synthetic hypericin, marketed as HyBryte™, in treating cutaneous T-cell lymphoma (CTCL). The study demonstrated comparable efficacy in both plaque and patch lesions caused by malignant T-cells. Synthetic hypericin has also shown efficacy in a Phase 1/2 proof of concept clinical study involving patients with both CTCL and psoriasis.

One of the significant advantages of synthetic hypericin therapy is its avoidance of the risk of secondary malignancies associated with DNA-damaging drugs and UV-dependent phototherapies. Additionally, it eliminates the risk of serious infections and cancer linked to systemic immunosuppressive treatments commonly used in psoriasis.

Psoriasis is a chronic inflammatory skin condition characterized by itchy, painful, and raised plaques covered with silvery-white scales. It has a detrimental impact on patients' quality of life and is associated with various comorbidities, including cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety and depression. Psoriasis is driven by autoimmune T-cell-mediated inflammation and is influenced by genetic and environmental factors.

The severity of psoriasis varies, with mild, moderate, and severe classifications based on the percentage of body surface area affected. Approximately 80% of patients have mild-to-moderate disease. Psoriatic arthritis, a chronic inflammatory arthritis, can also develop in a subset of individuals with psoriasis. Severe psoriasis has been associated with an increased relative risk of lymphoma, particularly CTCL. Onset of psoriasis typically occurs before the age of 35.

Psoriasis treatment aims to manage symptoms and varies based on disease severity. Options range from topical treatments, including PDT, to systemic therapies for more severe cases. However, many systemic treatments and current photodynamic therapies utilizing UV light carry an increased risk of skin cancer.

Synthetic hypericin holds promise as a safer and effective treatment option for psoriasis, avoiding the long-term risks associated with other treatments. It represents an innovative approach to address the unmet medical needs of patients with psoriasis.

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