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FDA Awards $2.6 Million Grant for Expanded Study of Soligenix's HyBryte for CTCL

NEW YORK, NY - (NewMediaWire) - September 12, 2022 - PCG Digital -- Late-stage biopharmaceutical company Soligenix, Inc. (Nasdaq: SNGX) has announced the award of a $2.6 million grant from the FDA to support a study of expanded HyBryte™ treatment, including at-home usage. The FDA’s support will give patients an opportunity to access Soligenix’s HyBryte™ therapy in an open-label setting. HyBryte is a novel skin directed photodynamic therapy for cutaneous T-cell lymphoma (CTCL), a rare skin disease and cancer. 

The Orphan Products Development grant, totaling $2.6 million over four years, was awarded to a prestigious academic institution that was a leading enroller in Soligenix’s successful Phase 3 study in the treatment of early stage CTCL. The study will enhance Soligenix’s safety database and provide further real-world evidence into the practical use of HyBryte™; it is expected to launch in Q4 2022.

Following the largest placebo controlled, randomized Phase 3 trial ever done in (CTCL), HyBryte™ has been found to be safe and well-tolerated, and to significantly reduce CTCL lesion size. Results of Soligenix’s positive Phase 3 FLASH (fluorescent Light Activated Synthetic Hypericin) were recently published in the international peer-reviewed journal, JAMA Dermatology. 

FDA grant to power expansive home use opportunity

"We are pleased the FDA is supporting the HyBryte™ program and giving patients an opportunity to access the therapy in an open-label setting," stated Christopher J. Schaber, President and CEO of Soligenix, Inc. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options.  The Phase 3 results provide the basis for our upcoming marketing application and this study will serve to embark on potential home-use of the therapy, augment the safety database as well as provide further real-world evidence into the practical use of HyBryte™ once commercially available."

Noting the growing need for a safe and effective treatment, Soligenix aims to develop HyBryte for home use within 18 months of receiving FDA approval. Patients could transition from in-office to at-home treatments with an accessible home unit that's supervised by telemedicine and no longer limited by geography. Transitioning to home unit use would potentially save patients time in terms of travel and may lead to better adherence and better responses. A longer study timeline will give patients the flexibility to try treatments in the comfort of their home with the aim of also benefiting overall responses and satisfaction. The U.S. home medical equipment market is expected to exceed $20.4 billion by 2027.

Watch an interview with Soligenix’s lead investigator, Dr. Ellen Kim, here.

Continuing to add value across the healthcare spectrum

Based on the success of the HyBryte trials to date, Soligenix is also exploring the potential for synthetic hypericin as a treatment for psoriasis. According to JAMA Dermatology, more than 7.5 million people in the U.S. are living with psoriasis, which can be triggered by stress, colds and infections, creating scaly, itchy and uncomfortable skin patches.

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. Current treatments vary from topical options including photodynamic therapy to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease.  Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.

In June, the company announced that the FDA had cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial in psoriasis, which is targeted for 4Q22. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.

Watch the Soligenix interview discussing psoriasis treatment with Dr. Neal Bhatia here.


This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See

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