Met Primary and All Secondary Endpoints with Statistically Significant Results Compared with
Conference call with
“We are thrilled to announce these robust positive results across all endpoints, which corroborate our previous positive EU Phase 3 clinical study results and clearly demonstrate the significant beneficial impact NexoBrid has on patients’ lives,” said Gal Cohen, President and Chief Executive Officer of
NexoBrid Phase 3 Study Design and Objectives
The NexoBrid DETECT study is a prospective, controlled, multi-center, multi-national, assessor blinded Phase 3 study in 175 patients randomized to either NexoBrid, Standard of Care (SOC), or the Gel Vehicle placebo at a ratio of 3:3:1, with 12- and 24-month long-term safety follow-up. The study involves 44 burn centers. The study objectives are to evaluate the efficacy and safety of NexoBrid by removing burn eschar earlier and reducing surgical burden and related blood loss in hospitalized patients with severe burns.
Complete eschar removal was the primary endpoint of the study and was tested against the Gel Vehicle control arm. The primary analysis was based on whether complete eschar removal was achieved in all target wounds of a patient. The analysis compared all randomized patients to the NexoBrid arm to all randomized patients to the Gel Vehicle control arm.
Secondary endpoints included reduction in the need for surgical eschar removal (surgical burden), earlier eschar removal, and blood loss, which were tested against the SOC control arm. All secondary endpoints were analyzed and compared all patients randomized to the NexoBrid arm to all patients randomized to the SOC control arm.
Time to complete wound closure (non-inferiority) and other standard safety measurements were also compared with the SOC control arm.
Funding and support for this pivotal U.S. Phase 3 clinical study (DETECT) with NexoBrid is provided by the
Demographics and other baseline characteristics
The overall patient demographics and wound baseline characteristics were comparable across study arms.
Summary of Study Results
|Primary end point:|
|Incidence of complete debridement||93.3% (70/75)||4.0% (1/25)||NA||P<0.0001|
|Incidence of surgical eschar removal||4.0% (3/75)||NA||72.0% (54/75)||P<0.0001|
|Time to achieve complete eschar removal||1.0 days||NA||3.8 days||P<0.0001|
||14.2 ml||NA||814.5 ml||P<0.0001|
|Non inferiority in time to complete wound closure||NA||P=0.0003|
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 (NexoBrid: 93.3% (70/75) vs. Gel Vehicle: 4.0% (1/25), p<0.00011).
The study included secondary endpoints that were all met with statistical significance and provided further insight on several efficacy parameters.
Patients treated with NexoBrid demonstrated a significantly lower incidence of surgical eschar removal compared with patients treated with SOC (NexoBrid: 4.0% (3/75) vs. SOC: 72.0% (54/75), p<0.00012).
Patients treated with NexoBrid demonstrated a significantly shorter time to achieve complete eschar removal compared with patients treated with SOC (median time - NexoBrid: 1.0 days vs. SOC: 3.8 days, p<0.00013).
Patients treated with NexoBrid incurred significantly lower blood loss during the eschar removal procedure compared with patients treated with SOC (mean volume – NexoBrid: 14.2 ml vs. SOC: 814.5 ml, p<0.00014).
Patients treated with NexoBrid had a non-inferior time to complete wound closure compared with patients treated with SOC (p=0.00035).
The overall safety profile of NexoBrid in the study is good, and consistent with the safety data known from previous studies.
Long-Term Safety Follow up
The planned twelve-month and twenty four-month safety follow-ups for cosmesis, function, quality of life and safety measurements are ongoing, and the Company expects to submit to the
Biological License Application (BLA) Submission Plan
The Company plans to submit the BLA in the second half of 2019 based on the above available acute primary, secondary, and safety data with the twelve-month safety follow-up data submitted during the BLA review, subject to
“This Phase 3 study is one of the most comprehensive randomized controlled studies ever conducted in burn care, and we are very pleased to see such compelling results,” stated Prof.
Stephen T. Wills, MediWound's Chairman added, “We thank all of the Principal Investigators, their teams, and our management and team for their tireless work and endless commitment in an effort to advance burn care. Based on these highly compelling top-line phase 3 results, it is gratifying to know that NexoBrid is one step closer to being available to help burn victims in the U.S., and we look forward to submitting a BLA in the second half of 2019, subject to
MediWound management will host a conference call for investors today,
A replay of the call will be accessible two hours after its completion through
For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended
Chief Financial and Operations Officer
LifeSci Advisors, LLC
1 Fisher's exact test
2 Logistic regression model - Wald test
3 Generalized Wilcoxon-Gehan test
4 Wilcoxon test pooled using Rubin's rules
5 Accelerated failure time model
Source: MediWound Ltd.