Soligenix Receives USAN Approval for "Hypericin Sodium" as Nonproprietary Name for Novel Active Ingredient in HyBryte™ and SGX302

PRINCETON, N.J., April 5, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States Adopted Names (USAN) Council has approved the use of the nonproprietary name of "hypericin sodium" for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX302 for the treatment of mild-to-moderate psoriasis.

"We are pleased that USAN has approved the proposed name," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to continuing to work with the World Health Organization (WHO) to advance the International Nonproprietary Name (INN) hypericin from a proposed INN to a recommended INN, which is expected to occur later this year."

Information on hypericin sodium will be posted on the USAN website (www.ama-assn.org/go/usan) before the end of 2023 and will be submitted to the U.S. Pharmacopeial Convention for publication in the U.S. Pharmacopeia Dictionary of USAN and International Drug Names.

About USAN

The USAN Council serves health professionals in the U.S. by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships to ensure that drug information is communicated accurately and unambiguously. The USAN Council aims for global standardization and unification of drug nomenclature by working closely with the International Nonproprietary Name Program of WHO and various national nomenclature groups.

About Synthetic Hypericin Sodium

Visible light-activated synthetic hypericin sodium is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin sodium is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of both CTCL and psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet (UV) light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in previous clinical trials.

This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin sodium coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in CTCL and psoriasis. 

In a published Phase 1/2 proof of concept clinical study using synthetic hypericin sodium, efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) as well as psoriasis (80% response, p