Soligenix Submits Type A Meeting Request for FDA Review of Confirmatory Phase 3 Study Design

Late-stage biotechnology company, Soligenix, Inc., (Nasdaq: SNGX) has submitted a Type A meeting request to the FDA to review its proposed study design for a second Phase 3 Study evaluating HyBryte™ in the treatment of cutaneous T-cell lymphoma (CTCL).

The Type A meeting is the highest priority classification of meeting the FDA grants and is expected to occur approximately 30 days from the FDA’s receipt of Soligenix’s meeting request. Soligenix stated its appreciation for the FDA’s responsiveness and continued collaboration demonstrated by categorizing this meeting as a Type A meeting.

Highlights

 Soligenix has submitted a meeting request to the FDA to initiate formal discussions regarding the design of a second, Phase 3 pivotal study evaluating HyBryte™ (hypericin sodium) in the treatment of early stage CTCL, a rare cancer.

In April 2023, Soligenix attended a Type A meeting with the FDA. The FDA expressed its understanding of the need for additional therapies in CTCL, its willingness to work with Soligenix and provided significant insights regarding the design of a future Phase 3 trial.

The company has previously successfully demonstrated statistically significant results in a Phase 3 clinical trial assessing HyBryte™ in CTCL.

HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation.

HyBryte™ is a potent photosensitizer that is topically applied to skin lesions, taken up by malignant T-cells, and then activated by visible light approximately 24 hours later.

About Soligenix

Soligenix is a late-stage biopharmaceutical company developing and commercializing products to treat rare diseases where there is an unmet medical need.   The company’s Specialized BioTherapeutics business segment is moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). Soligenix’s development programs also include synthetic hypericin (SGX302) as a potential treatment for psoriasis and dusquetide (SGX942) for the treatment of inflammatory diseases. Soligenix’s Public Health Solutions business segment includes active development programs for RiVax®, a ricin toxin vaccine candidate, SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease, vaccine programs targeting filoviruses and CiVax™, a vaccine candidate for COVID-19.

 

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Soligenix Submits Type A Meeting Request for FDA Review of Confirmatory Phase 3 Study Design

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