NexoBrid®

Disruptive Therapy for Burn Care

Introducing a New Paradigm in Treatment of Severe Burns

  • Indication:Eschar removal of deep partial and full thickness burns
  • Classification:Orphan Biological drug
  • Target Audience:Hospitalized patients
  • Status:DA/EU/JP approved; supplemental BLA for pediatric indication under review by the FDA
www.nexobrid.com

NexoBrid, a concentrate of proteolytic enzymes enriched in bromelain, is an easy to use, topically-applied product that removes eschar in four hours and does not harm the surrounding healthy tissues. Eschar removal is a critical first step in the treatment of severe burns. Under existing standard of care, burn eschar may be removed either by surgical approach, primarily surgical excision, which is traumatic and may result in loss of blood and viable tissue or by non-surgical approach, employing certain existing topical agents that have been found to be minimally effective or that take a significantly longer period of time to work.

NexoBrid’s rapid and selective debridement alleviates the known risks associated with eschar, such as infection, eventual sepsis, wound deterioration and consequential scarringand it allows physicians to reach an informed decision on further treatment at an earlier stage by direct visual assessment of the actual burn depth.

Furthermore, NexoBrid minimizes the burden associated with invasive surgical procedures, reduces the need for skin grafting and sacrifice of healthy tissue from donor sites on a patient’s body and generally results in a more favorable overall long-term patient outcome.

Severe burns require specialized care in hospitals or burn centers. Approximately 100,000 patients with severe burns are hospitalized every year in the United States and Europe. The severe burn patients are predominantly treated by specialists in approximately 250 burn centers in Europe and the United States, as well as at burn units of large hospitals.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201500035C.

How to Use

Early, effective and selective non-surgical eschar removal for severe burns

NexoBrid removes the eschar and does not harm surrounding viable tissue, in the majority of cases, after only a single 4-hour topical application at the patients’ bedside. This early, non-surgical, successful eschar removal, allows the physician to diagnose the burn depth simply by direct visual assessment of the debrided clean wound bed and reach an informed decision on further treatment.

Furthermore, NexoBrid effective eschar removal significantly reduces the extent of surgery required, without sacrificing the surrounding healthy tissues. The application is easy-to use and can be applied by a physician or a nurse.

NexoBrid’s effective and selective activity is mediated by the proteolytic activity of the enzymes, which leads to degradation of denatured collagen.

The Supplemental BLA for pediatric indication was accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.

The NexoBrid temperature-stable formulation development for use as a non-surgical solution in field-care burn treatment for the U.S. Army is progressing as planned. FDA feedback on the development path is expected in the second half of 2024.

Enrollment and 12-month follow-up for the Expanded Access Treatment Protocol (NEXT) have been concluded: 239 burn patients have been treated across 29 U.S. centers. Data readout is anticipated in the second half of 2024.

Facts

Lets Talk Numbers

>12000

TREATED PATIENTS

120

PUBLICATIONS

5

Strategic partnerships

100

Clinical sites Used Nexobrid

44

Countries

15

Distributors

Scientific Evidence

U.S Phase 3 Study (DETECT)

NexoBrid has been investigated in hundreds of patients across 22 countries and four continents in nine completed Phase 2 and Phase 3 and post-marketing clinical studies.

Our U.S. Phase 3 study (DETECT) evaluated the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to SOC in 175 hospitalized patients with severe burns with twelve month and twenty four month safety follow-ups. The study met its primary endpoint with statistical significance. Patients treated with NexoBrid demonstrated a significantly higher incidence of complete eschar removal compared with patients treated with the Gel Vehicle.  The study included secondary endpoints that were all met with statistical significance and provided further insight on several efficacy parameters:

(i) Patients treated with NexoBrid demonstrated shorter time to achieve complete eschar removal compared with patients treated with Standard of Care (SOC); (ii) Patients treated with NexoBrid demonstrated a significantly lower incidence of surgical eschar removal compared with patients treated with SOC; (iii) and Patients treated with NexoBrid incurred significantly lower blood loss during the eschar removal procedure compared with patients treated with SOC. In addition, Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC. The overall safety profile of NexoBrid in the study is consistent with the safety data known from previous studies. The twelve- and twenty four-month patients’ follow-up safety data of cosmesis, function and quality of life were found to be comparable across all study arms, and no safety signals were observed.

U.S Phase 3 Study (DETECT) Results

29

Clinical Sites

175

Patients

01

Incidence of complete eschar removal

02

Time to complete eschar removal [days]

03

Incidence of surgical eschar removal

Publications

Selected Publications:

Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial

Yaron Shoham, MD1, ; Lior Rosenberg, MD1; William Hickerson, MD2,3, ; Jeremy Goverman, MD4; Narayan Iyer, PhD5; Julio Barrera-Oro, PhD, MD5; Bretislav Lipovy, MD6, ; Stan Monstrey, MD7; Sigrid Blome-Eberwein, MD8; Lucy A Wibbenmeyer, MD9; Martin Scharpenberg, PhD10, ; Adam J. Singer, MD11,*, ; for the DETECT Investigators October 11, 2023

Bromelain-based enzymatic burn debridement: A systematic review of clinical studies on patient safety, efficacy and long-term outcomes

Yaron Shoham1 | Konstantinos Gasteratos 2 | Adam J. Singer 3 | Yuval Krieger 1 | Eldad Silberstein1 | Jeremy Goverman4June 28, 2023

Eschar removal by bromelain based enzymatic debridement (Nexobrid) in burns: European consensus guidelines update

Christoph Hirche, Stian Kreken Almeland, Baljit Dheansa, Paul Fuchs, Maurizio Governa, Henk Hoeksema, Tomasz Korzeniowski, David B. Lumenta, Silviu Marinescu, José Ramón Martinez-Mendez, Jan A. Plock, Frank Sander, Benjamin Ziegler, Ulrich KneserMarch 1, 2020

Enzymatic degradation of in vitro Staphylococcus aureus biofilms supplemented with human plasma

Chase M Watters1,2 Tarea Burton1 Dickson K Kirui1 Nancy J MillenbaughApril 27, 2016

MINIMALLY INVASIVE BURN CARE: A REVIEW OF SEVEN CLINICAL STUDIES OF RAPID AND SELECTIVE DEBRIDEMENT USING A BROMELAIN-BASED DEBRIDING ENZYME (NEXOBRID® )

Rosenberg L., 1,2,3* Shoham Y., 1 krieger Y., 1 Rubin G., 4 Sander F., 5 koller J., 6 David k., 3 egosi D., 7 Ahuja R., 8 Singer A.JDecember 1, 2015

A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT

Lior Rosenberg, Yuval Krieger, Alex Bogdanov-Berezovski, Eldad Silberstein, Yaron Shoham, Adam J. SingerAugust 9, 2013

Histological assessment of tangentially excised burn eschars

Reuven Gurfinkel MD1, Lior Rosenberg MD1, Sarit Cohen MD1, Arnon Cohen MD1, Alex Barezovsky MD1, Emanuela Cagnano MD2, Adam J Singer MD3September 1, 2010

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