Abeona anounced positive results in its Pivotal Phase 3 VIITAL Study of EB-101
Abeonas Phase 3 VIITAL study assessed the safety and efficacy of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).
EB-101 is an autologous, engineered cell therapy. Treatment with EB-101 involves using gene transfer to deliver the COL7A1 gene into a patient’s own skin cells (keratinocytes and its progenitors) and transplanting those cells back to the patient. EB-101 is being investigated for its ability to enable normal Type VII collagen expression and to facilitate wound healing.
The VIITAL study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds.
- Primary endpoint measuring >50% wound healing
- Other endpoints measuring >75% and complete wound healing at six months all met
- Co-primary endpoint measuring pain reduction at six months met; greater magnitude of pain reduction benefit was observed in post-hoc analysis of EB-101 treated wounds with severe baseline pain
- EB-101 was well-tolerated with no serious treatment-related adverse events, consistent with past clinical experience
- Based on the efficacy and safety profile of EB-101 in VIITAL, Abeona is looking forward to sharing the VIITAL study results with the FDA and progressing toward submission of a BLA in the second quarter of 2023.
These results show new clinical evidence of EB-101’s potential to treat the more difficult chronic and large wounds.