Product Description
D-Fi (dabocemagene autoficel, formerly known as FCX-007), is being developed as a disease-modifying, autologous cell-based gene therapy to address the deficiency of functional type VII collagen protein (COL7) in patients with autosomally recessive or dominant dystrophic epidermolysis bullosa, or DEB.
Mechanisms of Action: Gene Therapy,Type 7 Collagen
Novel Mechanism: Yes
Modality: Gene Therapy
Route of Administration: Injection
FDA Designation: Orphan Drug - Epidermolysis Bullosa *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Castle Creek
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Epidermolysis Bullosa Dystrophica
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| DEFI-RDEB | P3 |
Active, not recruiting |
Epidermolysis Bullosa Dystrophica |
2023-01-17 |
16% |
2023-04-28 |
Primary Completion Date|Primary Endpoints|Treatments |