The study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and reduction in need for autograft in deep partial burns, as well as a favorable trend in reduction of blood loss during the eschar removal process. In addition, the study showed that NexoBrid was safe and well-tolerated.
“We are thrilled to see such robust results across all primary endpoints, which corroborate the positive results of our pivotal phase 3 clinical studies in adult patients, and clearly demonstrate the significant beneficial impact NexoBrid has on the lives of pediatric burn patients,” said
Dr. Lior Rosenberg, MediWound's Chief Medical Technology Officer, added, “This study is one of the most comprehensive randomized controlled studies ever conducted in burn care generally and within the pediatric population specifically. We thank all the Principal Investigators and their teams, as well as the patients and their families, for their work and commitment to advance burn care. We also thank the
CIDS Study Design and Objectives
The NexoBrid CIDS study is a multicenter, multinational, randomized, controlled, open label study, performed in children with deep partial thickness (DPT) and full thickness (FT) thermal burns. The study's objectives are to evaluate the efficacy and safety of treatment with NexoBrid compared with standard of care (SOC) in hospitalized children with severe thermal burns of 1 percent to 30 percent Total Body Surface Area (TBSA). The study enrolled 145 pediatric patients, from newborn to eighteen years of age, randomized to either NexoBrid or SOC at a ratio of 1:1, across 36 burn centers worldwide. Topline results include acute phase and twelve-month follow-up data analysis. The long-term follow-up for cosmesis and function, quality of life and safety measurements is ongoing, and data is expected in the first half of 2023.
The study was expanded to include burn centers in
Funding and support for this pivotal pediatric Phase 3 clinical study (CIDS) with NexoBrid is provided by the
Summary of Study Topline Results
Demographics and other baseline characteristics
The overall patient demographics and wound baseline characteristics were comparable across study arms.
The study met its three primary endpoints with highly statistical significance. Patients treated with NexoBrid demonstrated a significantly shorter time to achieve complete eschar removal compared with patients treated with SOC (median time to complete eschar removal - NexoBrid: 0.99 days vs. SOC: 5.99 days, p=0.00081).
Patients treated with NexoBrid demonstrated a significant reduction in surgical need for excisional eschar removal as measured by an analysis of percent wound area surgically excised for eschar removal. Patients treated with NexoBrid incurred a significantly lower percent of wound area surgically excised for eschar removal compared with patients treated with SOC (NexoBrid: 1.5% vs. SOC: 48.1%, p<0.0001).
The non-inferiority analysis of cosmesis and function of scars (quality of scars) measured by MVSS (modified
The study included several secondary endpoints that provided further insight on additional efficacy parameters.
Patients treated with NexoBrid demonstrated a statistically significant lower incidence of surgical excision for eschar removal compared with patients treated with SOC (NexoBrid: 8.33% (6/72) vs. SOC: 64.38% (47/73), p<0.0001).
Patients treated with NexoBrid incurred lower blood loss during the eschar removal procedure compared with patients treated with SOC, demonstrating a clear trend in favor of NexoBrid (mean volume – NexoBrid: 32.36 ml vs. SOC: 202.55 ml, p=0.134).
Patients treated with NexoBrid demonstrated significant reduction of incidence of autograft performed in DPT wounds (on a target wounds level analysis) compared with patients treated with SOC (NexoBrid: 25.93% (21/81) vs. SOC: 37.63% (26/69), p=0.05).
Patients treated with NexoBrid incurred a numerically lower percent area of DPT wound autografted compared with patients treated with SOC (NexoBrid: 15.9% vs. SOC: 22.8%, p=0.5).
No deleterious effect on wound healing was observed. Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC (p=0.01491). Estimated median time to complete wound closure, using
The study DSMB (Data Safety Monitoring Board) reviewed the data of all subjects and found NexoBrid to
be safe and well tolerated. No safety concerns were identified in the study population.
NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the
EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the
These and other significant factors are discussed in greater detail in MediWound’s Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
Chief Financial Officer
1 Generalized Wilcoxon-Gehan test
Source: MediWound Ltd.