MediWound, an Israeli firm developing advanced enzymatic therapies for tissue repair, announced the successful outcomes of NexoBrid from the NEXT Expanded Access Protocol.
NexoBrid is a topically applied biological product designed to enzymatically remove nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns while preserving healthy tissue.
Approved in over 40 countries, including the US, the European Union, and Japan, NexoBrid has also been designated as an orphan biologic drug in each of these regions.
Started in 2019, NEXT was designed to ensure the continuous availability of NexoBrid in burn centres before its official commercialisation.
The initiative preserved physician expertise and ensured that burn victims continued to receive this treatment. It also allowed the collection of real-world safety and clinical data for NexoBrid.
NEXT is an open-label, single-arm treatment protocol, carried out at 29 burn centres across the US.
It enrolled a total of 239 patients, comprising 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA).
According to key results from NEXT Protocol, the efficacy findings were consistent with Phase 3 study results.
NexoBrid achieved complete debridement in 94.9% of adults and 100% of children.
Only 4.2% of adults required additional surgical excision for eschar removal, with none in the paediatric group.
On average, 3.6% of the wound area was surgically excised in adults, while no excision was needed for children. The time to complete eschar removal was less than one day for both groups.
For healing and hospitalisation, the median time to wound closure was 22 days for adults and 28 days for children. Both groups had a median hospitalisation duration of 10 days.
Harvard Medical School associate professor of surgery Jeremy Goverman said: “This enzymatic debridement agent accelerates the debridement process and reduces the need for surgical interventions, ultimately enhancing patient outcomes.
“The findings from NEXT are consistent with data from the DETECT and CIDS Phase 3 trials, reinforcing the critical role that NexoBrid should play in standard burn care protocols.”
In January, MediWound received the US Food and Drug Administration’s (FDA) acceptance to review a supplement to the NexoBrid biologics license application (sBLA) for using NexoBrid to remove eschar in paediatric patients with severe thermal burns.
