Soligenix Achieves Successful Transfer of Synthetic Hypericin Manufacturing to the U.S.

Soligenix Achieves Manufacturing Milestone

Overview

On July 1, 2025, Soligenix, Inc. (Nasdaq: SNGX) announced significant news regarding its synthetic hypericin—a key active ingredient in innovative treatments for cutaneous T-cell lymphoma (CTCL) and psoriasis. The company has successfully completed the transfer of its manufacturing process to Sterling Pharma Solutions in the U.S. This milestone marks a critical step in the development and commercialization of its products to treat rare diseases, particularly in areas where existing treatment options are lacking.

Key Developments

The transfer involved optimizing and implementing a production process that is not only commercially viable but also scalable, allowing Soligenix to produce larger quantities of cGMP (current good manufacturing practice) synthetic hypericin. This active ingredient is used in the formulations of HyBryte™ and SGX302, both of which are under development to combat CTCL and psoriasis, respectively.

Dr. Christopher J. Schaber, President and CEO of Soligenix, expressed his excitement over the completion of this transfer. He remarked, "We are pleased to have successfully produced larger quantities of cGMP synthetic hypericin and look forward to refining the process further to enhance efficiency and reduce costs." This signals a commitment not only to product development but also to a long-term partnership with Sterling Pharma Solutions, known for its expertise in active pharmaceutical ingredient manufacturing.

What is HyBryte™?

HyBryte™, which utilizes synthetic hypericin as its active ingredient, represents a groundbreaking approach in photodynamic therapy. It leverages safe visible light to activate hypericin, which specifically targets malignant T-cells in skin lesions. This method avoids the risks associated with traditional skin treatments that often employ DNA-damaging drugs and ultraviolet light, which can increase the chances of secondary malignancies, including melanoma.

The efficacy of HyBryte™ has been assessed in clinical settings, showing substantial promise. In a Phase 2 clinical trial, patients exhibited a statistically significant response to the topical application of hypericin compared to a placebo. Following these encouraging results, a Phase 3 clinical trial, named FLASH, was conducted with 169 patients. The trial demonstrated a 16% response rate among participants treated with HyBryte™ after the first six weeks, with significant improvements noted in subsequent treatment cycles.

Implications for Patients

This development is particularly crucial as CTCL is a rare form of non-Hodgkin lymphoma that predominantly affects T-cells. It presents significant treatment challenges and is associated with varied prognosis depending on the disease stage. Current treatments often fall short, emphasizing the need for innovative options like HyBryte™ that prioritize patient safety and efficacy.

Notably, HyBryte™ was awarded both orphan drug and fast track designations from the FDA, highlighting its potential to meet urgent medical needs in treating CTCL. The upcoming FLASH2 study aims to further validate its effectiveness, following regulatory discussions with authorities.

The Future of Soligenix

With successful manufacturing logistics in place and ongoing clinical trials, Soligenix is positioned to take a leading role in the biopharmaceutical landscape for rare diseases. Their focus on bringing advanced treatments to market aligns with their mission to address areas of significant unmet medical need. In addition to HyBryte™, the company is also advancing other treatments including SGX302 for psoriasis and various vaccine candidates for infectious diseases.

Conclusion

Soligenix's recent achievement in transferring synthetic hypericin manufacturing to the U.S. not only accelerates the development of innovative therapies but also strengthens its commitment to patient care. With ongoing studies and partnerships, the future looks promising for the company and those suffering from rare diseases like CTCL and psoriasis. It's an exciting time for innovation in the biopharmaceutical field, and Soligenix is at the forefront of this critical endeavor.