Soligenix Inc (SNGX)

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SNGX 4/05/2023 receives approval for HyBryte...

- "Soligenix Receives USAN Approval for "Hypericin Sodium" as Nonproprietary Name for Novel Active Ingredient in HyBryte™ and SGX302. 7:30 am ET April 5, 2023 (PR Newswire).
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," statedChristopher J. Schaber, PhD, President and Chief Executive Officer ofSoligenix. "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<0.02).
- The recently published Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin)studyenrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ (the tradename used in CTCL) treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte™ increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.

In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
- A HyBryte™ new drug application (NDA) has been submitted for the treatment of CTCL with the U.S. Food and Drug Administration (FDA). It is currently the subject of an FDA Refusal to File(RTF) letter, as upon preliminary assessment, the FDA determined that it was not sufficiently complete to permit substantive review. A Type A meeting with the FDA has been scheduled to gain further clarity and to respond to the issues identified in the RTF letter, as well as to seek additional guidance concerning information that the agency would require for a resubmitted NDA to be deemed acceptable.
- SGX302 (synthetic hypericin sodium) is currently being evaluated in a Phase 2a clinical trial targeting enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. The study is divided into two parts. In Part A, 5-10 patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment."

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