Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hypericin · 4 trials · 6 indications
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 |
|---|---|---|
| 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. |
| 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. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
| Placebo (Ointment without Hypericin) | PLACEBO_COMPARATOR | Placebo ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
| SGX302 Gel (0.25 % hypericin) | EXPERIMENTAL | SGX302 (0.25 % hypericin) gelt will be applied to lesions and treated with visible light 24±6 hours later starting at 5 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 |
|---|---|---|
| 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. |
| Placebo | DRUG | Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin. |
Inclusion Criteria: * Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A. (Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B:...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
Hypericin is an investigational small molecule being studied for dermatologic conditions, specifically cutaneous T-cell lymphoma (CTCL), mycosis fungoides, and mild-to-moderate psoriasis. It is developed by Soligenix, Inc. (SNGX) and is currently in Phase 2 clinical development.
Hypericin is a photosensitizing agent that, when activated by visible light, produces a therapeutic effect in treated skin lesions. It is being studied for topical treatment of cutaneous T-cell lymphoma and psoriasis, where light activation is intended to target diseased cells in the skin.
Hypericin is developed by Soligenix, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker SNGX. The company is conducting Phase 2 clinical trials of Hypericin for cutaneous T-cell lymphoma and psoriasis.
Hypericin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Multiple Phase 2 trials have been completed, including studies in cutaneous T-cell lymphoma and psoriasis, but it remains in clinical testing.
Hypericin has been studied in several completed Phase 2 trials, including NCT05380635 for cutaneous T-cell lymphoma, NCT05442190 for psoriasis, NCT05872854 for mycosis fungoides, and NCT06149247 comparing Hypericin to Valchlor in CTCL. All trials were conducted in the United States.
Yes, Hypericin is also known as HyBryte, which is the brand name used in clinical trials for cutaneous T-cell lymphoma. The drug is also referred to as SGX302 in psoriasis trials. These names refer to the same synthetic hypericin compound developed by Soligenix.