Phase 3 VIITALTM Clinical Trial of EB-101
The VIITAL™ Phase 3 study will be a multi-center, randomized clinical trial assessing EB-101 in 10 to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total. The primary study endpoint will be the proportion of wounds with at least 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change in pain from baseline as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function.
Who is eligible to participate in the VIITALTM study?
Key criteria for eligible patients include the following, but a full list of inclusion and exclusion criteria are available here.
- Diagnosis of RDEB
- Age 6 years or older
- Positive expression of type VII collagen protein in the skin
- Two RDEB type VII collagen mutations
- ≥40 cm2 of chronically wounded areas on the trunk and/or extremities deemed suitable by the investigator for EB-101 treatment
- ≥2 matched eligible wound sites ≥20 cm2; present for ≥6 months, and stage 2 wound
About the VIITALTM Study
Recessive Dystrophic Epidermolysis Bullosa, or RDEB, is caused by a defect in the COL7A1 gene resulting in the inability to produce Type VII collagen, which plays an important role in anchoring the dermal and epidermal layers of the skin. The study involves gene transfer into a majority of cells in the outer layer of skin, using an ex vivo approach. Investigators will biopsy skin tissue, grow and multiply the cells, and then insert the correct type VII collagen gene. Inserting the gene may provide the cells with the properties to grow and develop normal skin. This process of inserting the correct gene, or "gene transfer," uses a vector virus. The vector is made so that it only delivers the gene and it should not spread to other parts of the body, which investigators monitor during the study. After cells have received gene transfer, they are grown into a skin patches of cells that look like a plastic film, before being transplanted back onto the patient. After treatment, patients are followed for 24 weeks to assess safety and efficacy.
For more information about enrolling in our clinical trials, contact us at EB@abeonatherapeutics.com.
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.