Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BF-200 ALA · 1 trial · 1 indication
Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.
| Arm | Type | Description |
|---|---|---|
| BF-200 ALA | ACTIVE_COMPARATOR | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin. |
| methyl-aminolevulinate | ACTIVE_COMPARATOR | Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin. |
| Name | Type | Description |
|---|---|---|
| BF-200 ALA | DRUG | Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation) |
| methyl-aminolevulinate | DRUG | Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation) |
Main Inclusion Criteria: * Willing and able to sign informed consent form; obtained in writing before starting any study procedures * Presence of 1-3 thin (≤2 mm thickness), clinically non-aggressive, primary BCC lesions (primary superficial, nodular, or mixed superficial/nodular) in the face/foreh...
BF-200 ALA is an investigational small molecule being developed for the treatment of actinic keratosis and basal cell carcinoma (BCC). It is administered with photodynamic therapy (PDT) for the field-directed treatment of actinic keratosis and for non-aggressive basal cell carcinoma. The drug is currently in Phase 3 clinical development.
BF-200 ALA is a small molecule used in photodynamic therapy (PDT). It is a formulation of aminolevulinic acid that is applied to the skin and activated by light to treat actinic keratosis and basal cell carcinoma. The therapy targets abnormal skin cells in the treated area.
BF-200 ALA is being developed by Biofrontera Inc., a biopharmaceutical company. The company is publicly traded on the NASDAQ under the ticker symbol BFRI. Biofrontera is conducting clinical trials to evaluate the safety and efficacy of BF-200 ALA for dermatological conditions.
BF-200 ALA is in Phase 3 clinical development for actinic keratosis and basal cell carcinoma. It is an investigational drug that has not been approved by regulatory authorities. The development program includes completed Phase 3 trials evaluating its use with photodynamic therapy for these skin conditions.
BF-200 ALA has been studied in four completed clinical trials. These include NCT01966120, a Phase 3 trial for actinic keratosis in Germany with 87 participants; NCT02144077, a Phase 3 trial for basal cell carcinoma with 281 participants; NCT02799069, a Phase 3 trial for actinic keratosis with 571 participants; and NCT05060237, a Phase 1 trial in the United States with 112 participants.
BF-200 ALA is also known as Ameluz. In clinical trials, it is referred to as BF-200 ALA (Ameluz) for photodynamic therapy. The drug is being studied for the treatment of actinic keratosis and basal cell carcinoma under this brand name.