Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D-Fi · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts | EXPERIMENTAL | Intra-subject randomized (paired wounds in each subject receive experimental treatment, D-Fi, or remain untreated). One target wound pair will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (D-Fi is administered) or control wound. Subjects will receive intradermal injections of D-Fi in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1, the second at Week 8/Month 2 and the third at Week 16/Month 4. Additional treatment sessions may occur at Week 26/Month 6, Week 32/Month 8 and Week 40/Month 10 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. |
| Name | Type | Description |
|---|---|---|
| D-Fi | BIOLOGICAL | D-Fi is composed of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen. |
Inclusion Criteria: * Male or female ≥2 years of age at the Screening visit * Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation. Exclusion Criteria: * Medical instability limiting ability to travel to the investigative site. * Active infection with human immunodeficiency viru...
D-Fi is an investigational monoclonal antibody being developed for the treatment of wounds due to dystrophic epidermolysis bullosa (DEB), a rare genetic skin disorder. It is currently in Phase 3 clinical development and has not been approved by the FDA.
D-Fi is being developed by Castle Biosciences, Inc. (NASDAQ: CSTL), a biopharmaceutical company focused on dermatologic diseases. The company is conducting a Phase 3 clinical trial of D-Fi in the United States.
D-Fi is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants.
D-Fi is being evaluated in a Phase 3 clinical trial with the identifier NCT06892639, titled "Evaluation of D-Fi for the Treatment of Wounds Due to DEB." The trial is enrolling 32 participants aged 2 years and older in the United States.
D-Fi is a monoclonal antibody, a type of biologic drug designed to bind to a specific target involved in the disease process. Its exact molecular target has not been disclosed in available information.