Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SGX301 · 1 trial · 1 indication
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.
| 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. |
| 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. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
SGX301 is an investigational small molecule being developed for the treatment of Cutaneous T-Cell Lymphoma, specifically mycosis fungoides. It is a topical synthetic hypericin formulation designed for use in this dermatologic condition. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
SGX301 is being developed by Soligenix, Inc., a biopharmaceutical company. Soligenix is publicly traded on the stock market under the ticker symbol SNGX. The company is conducting clinical trials to evaluate the safety and efficacy of SGX301 for the treatment of Cutaneous T-Cell Lymphoma.
SGX301 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received FDA approval. Its status indicates it is still undergoing clinical evaluation for the treatment of Cutaneous T-Cell Lymphoma.
SGX301 has been studied in a Phase 3 clinical trial with the identifier NCT02448381. This trial, titled FLASH, evaluated topical SGX301 for the treatment of Cutaneous T-Cell Lymphoma. The study enrolled 169 participants in the United States and has been completed. It was a randomized, double-blind, placebo-controlled trial.
SGX301 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial, NCT02448381, evaluated its use in Cutaneous T-Cell Lymphoma, but regulatory approval has not been granted. The drug remains under investigation for this indication.