Botanical drug may outperform standard of care for treatment of severe thermal burns
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Key takeaways:
- Phase 3 data shows NexoBrid allows for the early complete eschar removal in more than 90% of patients.
- This recently published data was used to support the drug’s FDA approval in 2022.
Results from DETECT, the phase 3 study that supported the FDA approval of NexoBrid for the treatment of severe thermal burns, was recently published in the Journal of Burn Care & Research, Vericel announced in a release.
NexoBrid (anacaulase-bcdb), a botanical drug containing proteolytic enzymes for the removal of eschar in adults with thermal burns, was approved by the FDA on Dec. 29, 2022. The phase 3 DETECT trial served as the foundation for the drug’s approval.
“Since 1970 surgeons have managed deep burns by surgical debridement and autografting,” Yaron Shoham, MD, a plastic and reconstructive surgeon at the Soroka University Medical Center and lead investigator of the trial, and colleagues wrote in the recently published study, describing the current standard of care treatment for deep burns. “We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as a standard of care.”
In the study, patients with deep burns covering 3% to 30% of their body were randomly assigned to be treated with NexoBrid (n = 77), surgical or non-surgical standard of care (n = 68) or a vehicle gel (n = 24).
Patients assigned to NexoBrid applied 2 g of sterile powder mixed with 20 g of sterile gel vehicle per 1% of the burn. After covering the burn edges with petrolatum gel, the wound was covered with an occlusive dressing for four hours. The researchers removed the dressing, agent and all dissolved eschar after 4 hours and then soaked the wound in an antibacterial solution for 2 hours before assessing results.
The same process was followed for those in the vehicle group except the dosage did not include the powder.
Results showed that NexoBrid highly outperformed the vehicle with 93% of patients achieving the primary endpoint of complete eschar removal at the end of the debridement phase compared with 4% in the vehicle group (P < .001).
Researchers also compared the proportion of patients who needed any surgical excision for eschar removal in the NexoBrid and standard of care treatment groups.
Expectedly, surgical excision was needed in 72% of the standard of care group but, unexpectedly, was only needed in 4% of the NexoBrid group (P < .001). Additionally, the odds of excision for the NexoBrid group decreased by 98.9% compared with the standard of care group (OR = .011; P < .0001).
Significantly less blood loss occurred in the NexoBrid group compared with the standard of care group (14 ml ± 512 ml vs. 814 ml ± 1,020 ml, respectively; P < .0001).
Scar appearance after 12 months in the NexoBrid group was also considered noninferior compared with the standard of care group (3.7 ± 2.1 vs. 5 ± 3.1, respectively) according to the Modified Vancouver Scar Scale that grades scars on a scale of 0 to 15, with 15 being the worst.
“These data demonstrate the ability of NexoBrid to provide patients with severe thermal burns safe and effective enzymatic eschar removal that is superior to current debridement methods,” Jon Hopper, MBA, chief medical officer of Vericel, said in the press release. “We are pleased that NexoBrid is now available to U.S. burn surgeons to treat severe burn patients and we believe the publication of these results, coupled with real-world clinical experience, will help establish NexoBrid as the new standard of care for eschar removal.”
Reference:
• Shoham Y, et al. J Burn Care Res. 2023;doi:10.1093/jbcr/irad142.
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