Soligenix Delivers Two Pivotal Milestones

Company Ends 2022 With New Drug Application (NDA) Filing and Phase 2 Psoriasis Study Underway

NEW YORK, NY - (NewMediaWire) - December 20, 2022 - PCG Digital -- Late clinical-stage biopharmaceutical company, Soligenix Inc., (Nasdaq: SNGX), delivered two transformative milestones to finish out 2022. On December 15, the company announced the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for HyBryte™ (synthetic hypericin), to treat cutaneous T-cell lymphoma (CTCL). 

Yesterday, the company initiated its Phase 2a clinical trial to evaluate SGX302 (synthetic hypericin) as a  treatment for mild-to-moderate psoriasis. These key milestones cap off a year of headlines and headway for Soligenix.

We caught up with Soligenix CEO Dr. Christopher Schaber to find out what this means for the future.

Q: Can you tell us more about the data leading up to the NDA submission?

A: The Phase 3 study to evaluate HyBryte™ as a treatment for CTCL is the largest placebo randomized controlled trial ever done in CTCL. The study showed that this combination of drug and light reduced the size of patients' skin lesions in six weeks. Importantly, the mounted response and the duration of response continue to dramatically increase as a patient continues therapy.

Most of the trials being done in CTCL are evaluating treatments for late-stage disease. HyBryte™, on the other hand, is targeted to the vast majority of patients who have early-stage disease and are likely to stay early-stage for years to decades.

Q: What is your strategy for bringing HyBryte to market? And what is the market size?

A: Soligenix plans to self-commercialize HyBryte in the United States rather than seeking a commercialization partnership. Since this is a specialized market, we believe we can effectively market the drug for less than $10 million in launch costs, maintaining 100% of the drug’s value. When it comes to international markets, we anticipate seeking a commercial partnership and we are currently in discussions with potential partners. We are seeking regulatory approval in the US initially, followed by other key markets worldwide. CTCL is a rare disease affecting over 25,000 individuals in the US, with approximately 3,000 new cases seen annually. We estimate the annual global market size for HyBryte to be in excess of $250 million.

Q. Soligenix has now initiated a Phase 2a clinical trial investigating synthetic hypericin for the treatment of mild-to-moderate psoriasis. Can you expand on that?

A: Psoriasis is a debilitating, incurable chronic condition affecting as many as 7.5 million people in the US and between 60 and 125 million people worldwide. Synthetic hypericin is the active ingredient in both SGX302 and HyBryte. We are motivated to expand synthetic hypericin’s development into different cutaneous T-cell diseases such as psoriasis as part of our long-term strategy to enhance the value of this unique compound. Given our promising published results with hypericin to date, including our Phase 3 FLASH study in cutaneous T-cell lymphoma, and a proof of concept study in psoriasis, we hope it will have a role to play in helping patients suffering from this difficult to treat disease.

Q: Soligenix has been the recipient of non-dilutive government funding for its programs in the past. Do you anticipate receiving additional funding in the future?

A: We are pleased to have had a level of success in bringing in non-dilutive funding over a number of years. We recently announced that HyBryte received a small FDA working grant of $2.6 million to fund an expanded study of HyBryte and the potential for its transition to a home-use setting.

In October 2022, Soligenix was invited by the Biomedical Advanced Research and Development Authority (BARDA) to submit a contract proposal for the development of thermostabilized subunit vaccines for Sudan ebolavirus and Marburg virus. This contract opportunity has the potential to be substantial, if awarded.

I can’t make any definitive statements about future funding, but we are always evaluating opportunities and regularly file applications for grants and contracts and look at ways to bring in non-dilutive funding to fund Soligenix’s pipeline and allow us to continue moving our programs forward.

Q: Soligenix's Public Health Solutions business segment has the potential to receive one or more FDA Priority Review Vouchers. What would this mean for the company?

A: Priority Review Vouchers (PRV) allow companies to have their drugs reviewed under the FDA's priority review system, speeding up the drug development process and allowing companies to go to market more quickly. PRVs are worth a considerable amount of money and can be sold by the holder to another company wanting to accelerate their review cycle. In 2020, a voucher sold for $111 million, showing the value they hold. Soligenix has the potential to receive up to three Priority Review Vouchers based on our work in our Public Health Solutions business segment, which would allow us to generate significant additional revenue in the event of a PRV sale.

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