Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Hypericin, SGX301, Synthetic Hypericin
SGX301 (synthetic hypericin) · 5 trials · 7 indications
The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome. The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.
A Treatment Response is defined as a ≥50% improvement in the Composite Assessment of Index Lesion Severity (CAILS) score score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the CAILS score at baseline. The CAILS score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome. The overall CAILS score is calculated by adding the total score as described above for each of the 3-5 index lesions. A lower score means a better outcome.
A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.
The percentage of patients in each treatment group that achieve a 0 or 1 score (Clear or Almost Clear) evaluation using the 5-point Investigator's Global Assessment (IGA) scale. The 5-point IGA scale: * Score 0: Clear - No signs of psoriasis; post-inflammatory hyperpigmentation may be present * Score 1: Almost Clear - No thickening; normal to pink coloration; no to minimal focal scaling * Score 2: Mild - Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling * Score 3: Moderate - Clear distinguishable to moderate thickening; dull to bright red; moderate scaling * Score 4: Severe - Severe thickening with hard edges; bright to deep red coloration; severe/coarse scaling covering almost all lesions
Assess any ECG QT interval changes (defined as any occurrences of QT interval \>500 ms or changes in QT interval \>60 ms) during standard HyBryte photodynamic therapy.
Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.
| Arm | Type | Description |
|---|---|---|
| SGX301 | ACTIVE_COMPARATOR | Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy. Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated. Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment. Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index). |
| Placebo | PLACEBO_COMPARATOR | Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical. |
| HyBryte (0.25 % Hypericin) with Visible Light | EXPERIMENTAL | HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm\^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks. |
| HyBryte (0.25 % hypericin) | EXPERIMENTAL | HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks. |
| Valchlor (mechlorethamine) | ACTIVE_COMPARATOR | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. |
| Cohort 1 - SGX302 Ointment (0.25 % Hypericin) | EXPERIMENTAL | SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2 with a gradual escalation of light therapy up to 25 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
| Cohort 2 - SGX302 Ointment (0.25 % Hypericin) | EXPERIMENTAL | SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2 with a faster escalation of light therapy up to 25 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
| Cohort 3 - SGX302 Gel (0.25 % Hypericin) | EXPERIMENTAL | SGX302 (0.25 % hypericin) gel will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2 with a faster escalation of light therapy up to 40 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
| Name | Type | Description |
|---|---|---|
| SGX301 (synthetic hypericin) | DRUG | 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light. |
| Placebo | DRUG | USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light. |
| Hypericin | DRUG | HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment |
| Visible Light | OTHER | After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte. |
| Mechlorethamine Topical Gel | DRUG | Valchlor is an FDA-approved drug for the treatment of CTCL. |
Inclusion Criteria: * Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA. * Subjects must have a minimum of three (3) evaluable, discrete lesions. * Subjects must be willing to refrain from sunbathing for the duration of the study. Exclusion Crite...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 1 | PHASE2 | Ruxolitinib |
SGX301 is being developed for the treatment of cutaneous T-cell lymphoma, including mycosis fungoides, and is also being studied in psoriasis. It is a topical small molecule therapy applied to skin lesions and then activated with visible light. It is investigational and has not been approved by the FDA.
SGX301 is developed by Soligenix, Inc., a biopharmaceutical company that trades under the ticker symbol SNGX. Soligenix is advancing the asset in dermatology, with cutaneous T-cell lymphoma as its lead indication and psoriasis as an additional area of study.
SGX301 has reached Phase 3 development. The clinical program includes completed Phase 2 trials in cutaneous T-cell lymphoma and psoriasis, and the drug remains investigational rather than approved. It has not received FDA approval for any indication.
Completed studies include NCT06149247, which compared synthetic hypericin with mechlorethamine in cutaneous T-cell lymphoma, and NCT05872854, which tested hypericin ointment with visible light in mycosis fungoides. NCT05442190 evaluated topical SGX302 in mild-to-moderate psoriasis, and NCT05380635 assessed pharmacokinetics and ECG effects over eight weeks of treatment.
Yes. SGX301 is a synthetic form of hypericin, and the names SGX301, synthetic hypericin, and hypericin are used interchangeably for this topical photodynamic therapy candidate. The related designation SGX302 has been used for the psoriasis program. Both refer to the same synthetic hypericin compound.
SGX301 is a small molecule photosensitizer. It is applied topically to affected skin and then activated by visible light, a technique known as photodynamic therapy. This light activation is intended to act on the treated skin lesions. The approach is being studied in cutaneous T-cell lymphoma and psoriasis.