NexoBrid® Clinical Study Design

The safety and efficacy of NexoBrid were evaluated in three clinical studies.1

Study 1 (Detect; NCT02148705)1

Three-arm Study with 3:3:1 Ratio

NexoBrid (n=75) vs SOC (n=75) vs Gel Vehicle (n=25)

  • Randomized, controlled, assessor-blinded, three-arm study
  • To evaluate the safety and efficacy of NexoBrid in comparison to standard of care (SOC) treatment and gel vehicle (placebo)
  • SOC included both surgical and non-surgical eschar removal methods per the investigators’ discretion
  • 175 randomized subjects with deep partial thickness (DPT) and/or full thickness (FT) thermal burns with ≤30% body surface area (BSA)
  • Subjects had one or more target wounds (TWs) to be treated for eschar removal. The mean percentage BSA of all TWs per subject was 6.1%. 82% of subjects had one to two TWs

Limitations:

Not studied in burns >30% TBSA, children, pregnant or nursing women, patients with cardiopulmonary disease, or patients with poorly controlled diabetes.2

Primary Endpoint (1°): NexoBrid vs Gel Vehicle1

Study 1 Primary Endpoint percentage icon

Incidence of ≥95% eschar removal at the end of the topical treatment period

See Results 

Secondary Endpoints (2°): NexoBrid vs SOC1

  • Median time to ≥95% eschar removal
  • Incidence of excision for eschar removal*

See Results 

Safety Endpoint: NexoBrid vs SOC1,2

  • Estimated median time to ≥95% wound closure

See Results 

Study 2 (NCT00324311)1

Two-arm study with 1:1 Ratio

NexoBrid (n=75) vs SOC (n=81)

  • Multicenter, open-label, randomized, two-arm study
  • To evaluate the safety and efficacy of NexoBrid in comparison to SOC treatment
  • SOC included both surgical and non-surgical eschar removal methods per the investigators’ discretion
  • 156 randomized subjects with DPT and/or FT thermal burns with ≤30% BSA

Limitations:

Not studied in burns >30% TBSA, patients with full or partial thickness facial burns, perineal and/or genital burns, pregnant women or nursing mothers, poorly controlled diabetes, and patients with cardiopulmonary disease.2

Primary Endpoints (1°): NexoBrid vs SOC1,3

Study 2 Primary Endpoint blade icon

Incidence of excision for eschar removal of DPT wounds (per wound)*

Study 2 Primary Endpoint tissue icon

Percent treated DPT wound autografted (per wound)

See Results 

Secondary Endpoints (2°): NexoBrid vs SOC1

  • Incidence of excision for eschar removal of DPT wounds (per subject)†
  • Estimated median time to ≥95% wound closure (per subject)

See Results 

*Measured the incidence of excision for eschar removal following treatment with NexoBrid vs standard of care (SOC), which included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

†Assessment per subject was an exploratory analysis.

Clinical Efficacy target icon

Clinical Efficacy

Review the Data 

NexoBrid Safety shield icon

Nexobrid Safety

Review Safety Data 

Study 3 (CIDS; NCT02278718)1

Two-arm Study with 1:1 Ratio

NexoBrid (n=72) vs SOC (n=73)

  • Open label, randomized, controlled, two-arm study
  • To evaluate the safety and efficacy of NexoBrid in comparison to standard of care (SOC) treatment in pediatric patients 7 months to 18 years of age
  • SOC included both surgical and non-surgical eschar removal methods per the investigators’ discretion
  • 145 randomized subjects with DPT and/or FT thermal burns with a mean of 5.6% BSA of all target wounds per subject

Limitations:

Not studied in burns >30% TBSA, patients with full or partial thickness facial burns, perineal and/or genital burns, pregnant women or nursing mothers, poorly controlled diabetes, and patients with cardiopulmonary disease.2

Primary Endpoint (1°): NexoBrid vs SOC1

Study 3 Primary Endpoint clock icon

Median time to ≥95% eschar removal

See Results 

Secondary Endpoints (2°): NexoBrid vs SOC1

  • Incidence of excision for eschar removal (per subject)*

See Results 

Safety Endpoint: NexoBrid vs SOC1,2

  • Estimated median time to ≥95% wound closure

See Results 

*Measured the incidence of excision for eschar removal following treatment with NexoBrid vs SOC, which included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

Clinical Efficacy target icon

Clinical Efficacy

Review the Data 

NexoBrid Safety shield icon

Nexobrid Safety

Review Safety Data 

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for treatment of:

  • Chemical or electrical burns
  • Burns on the face, perineum, or genitalia
  • Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease
  • Circumferential burns
  • Burns in patients with significant cardiopulmonary disease, including inhalation injury

NEXOBRID is not recommended for:

  • Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance
  • Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for treatment of:

  • Chemical or electrical burns
  • Burns on the face, perineum, or genitalia
  • Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease
  • Circumferential burns
  • Burns in patients with significant cardiopulmonary disease, including inhalation injury

NEXOBRID is not recommended for:

  • Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance
  • Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb. If a hypersensitivity reaction occurs, remove NEXOBRID (if applicable) and initiate appropriate therapy.

Healthcare personnel should take appropriate precautions to avoid exposure when preparing and handling NEXOBRID (e.g., gloves, surgical masks, other protective coverings, as needed).

Coagulopathy

Avoid use of NEXOBRID in patients with uncontrolled disorders of coagulation. Use with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.

Adverse Reactions

The most common adverse reactions (>5%) in adults were pruritus, pyrexia, wound complication, anemia, vomiting and insomnia. The most common adverse reactions (>5%) in pediatric patients were pruritus, pyrexia and vomiting.

Use in Special Populations
Geriatric Use

Clinical studies of NEXOBRID did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

To report negative side effects contact Vericel Corporation at 888-454-BURN (888-454-2876) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

References: 1. NexoBrid Prescribing Information. Cambridge, MA. Vericel Corporation; 2024. 2. Data on File. BLA 761192; July 2022 and October 2023. 3. Rosenberg L, Krieger Y, Bogdanov-Berezovski A, et al. A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns. 2014;40:466-474.