MediWound Announces Publication of the EscharEx Phase II ChronEx Study Results for Venous Leg Ulcers
MediWound Announces Publication of the EscharEx Phase II ChronEx Study Results for Venous Leg Ulcers
Research Published in THE LANCET's eClinicalMedicine
EscharEx Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue
《柳葉刀》eClinicalMedicine發表的研究
EscharEx在去除壞死組織和促進健康肉芽組織生成方面表現優於非手術標準護理。
YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella. The publication, titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study", reports the results of the study.
以色列亞夫內,2024年7月29日(GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD),全球下一代酶治療藥物修復領導者,今日宣佈了在享有《柳葉刀》科學論文發現旗下著名期刊eClinicalMedicine上,評估EscharEx治療靜脈潰瘍(VLU)的二期ChronEx研究經過同行評議的發表。該發表的標題爲《每日一次基於菠蘿酶的靜脈潰瘍酶性去除治療與凝膠載體(安慰劑)和非手術標準治療:一項三臂多中心、雙盲、隨機對照研究》,報告了 該研究的結果.
"The publication in eClinicalMedicine highlights the importance of a safe and effective non-surgical treatment for debridement of chronic wounds, particularly venous leg ulcers (VLUs). Removing non-viable tissue and promoting well-vascularized granulation tissue are essential steps in wound bed preparation, which is crucial for successful wound healing," stated Dr. John C. Lantis, Chief of Surgery at Mount Sinai West Hospital and principal investigator in the ChronEx study. "The significant superiority of EscharEx over the current non-surgical standard of care in achieving optimal wound bed preparation could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. This will be a primary focus of the upcoming EscharEx Phase III trial in treating VLUs."
「在eClinicalMedicine上的發表突出了一種安全有效的非手術治療對於治療慢性傷口,特別是靜脈潰瘍(VLUs)的重要性。清除非活性組織並促進良好血管化的肉芽組織生成是傷口牀準備的關鍵步驟,這對於成功癒合至關重要,」 Mount Sinai West醫院外科主任兼ChronEx研究的主要研究員John C. Lantis博士說道。「EscharEx在達到最佳傷口牀準備方面明顯優於當前的非手術標準護理,這可能極大地提高癒合效果,併爲手術性清創提供一種可行的替代方案。這將是即將到來的EscharEx三期治療VLUs試驗的主要焦點。」
The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks.
Phase II ChronEx研究在美國、歐洲和以色列的20家醫療中心和診所進行。患者按照3:3:2的比例被隨機分配接受每日治療的EscharEx、凝膠載體(安慰劑)或非手術標準護理(NSSOC),其中包括SANTYL、水凝膠、醫用等級蜂蜜和非活性敷料。治療持續時間最長爲兩週(最多每天使用八次),或者直到完全去除壞死組織。治療結束後,患者每週監測12周。
Key study outcomes include:
主要研究結果包括:
- A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm.
- Baseline characteristics of patients and wounds were comparable across all study arms.
- The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001).
- The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016).
- The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001).
- Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms.
- The safety profile of EscharEx was comparable to both NSSOC and the placebo.
- 共有119名患者隨機接受治療:EscharEx組46名,安慰劑組43名,NSSOC組30名。
- 三個治療組的基線特徵和傷口特徵相當。
- 研究達到了主要終點:兩週每天治療期間EscharEx完全去膠結物的發生率爲63.0%,安慰劑爲30.2%(P=0.004)。NSSOC每日治療期間完全去膠結物的發生率爲13.3%(P
- 完成去膠結物的中位時間爲EscharEx 9天,安慰劑63天(P=0.004),NSSOC 59天(P=0.016)。
- 每日治療期間傷口顆粒組織完全覆蓋的發生率,EscharEx爲50.0%,安慰劑爲25.6%(P=0.01),NSSOC爲10.0%(P
- 患者自報的疼痛、傷口大小或生活質量(QoL)的變化在三個治療組之間是可比的。
- EscharEx的安全性與NSSOC和安慰劑相當。
About EscharEx
關於EscharEx
EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing. MediWound is set to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024, and a Phase II/III study targeting Diabetic Foot Ulcers in the second half of 2025.
EscharEx是一種治療慢性和其他難以治癒傷口的新型生物活性多模式去膠結療法,目前處於臨床開發的後期階段。它是一種酶促劑濃縮物,富含溴酶,可以進行局部、易於使用的日常應用。在多項II期試驗中,EscharEx被證明是安全和耐受的。它在各種難以治癒的傷口的去膠結、顆粒組織促進和生物負荷和生物膜的減少方面表現出有效性,有效地準備了傷口牀以進行癒合。mediwound計劃在2024年下半年啓動靜脈性腿部潰瘍III期研究,並在2025年下半年啓動針對糖尿病足潰瘍的II/III期研究。
About MediWound
關於mediwound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.
mediwound(Nasdaq:MDWD)是全球非手術組織修復創新酵素治療領域的領導者。公司專注於開發、生產和銷售快速而有效的生物製品,以提高現有的護理標準和患者體驗,並降低成本和不必要的手術。
MediWound's first drug, NexoBrid, is an FDA and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company's lead drug under development, EscharEx. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market.
MediWound的首款藥物NexoBrid是FDA和EMA批准的孤兒生物製品,用於去除深部部分厚度和/或全厚度燒傷組織,可以顯著減少手術干預。利用相同的核心生物治療酶平台技術,MediWound開發了強大的研發管道,包括該公司正在開發的領先藥物EscharEx。 EscharEx是一種爲患者消除慢性傷口的生物治療藥物,爲市場帶來了重大潛力,並提供了重要的潛在優勢。
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Cautionary Note Regarding Forward-Looking Statements
關於前瞻性聲明的謹慎說明
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, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx. 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; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. 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, 2023, filed with the Securities and Exchange Commission ("SEC") on March 21, 2024 and 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.
MediWound Contacts: | |
Hani Luxenburg | Daniel Ferry |
Chief Financial Officer | Managing Director |
MediWound Ltd. | LifeSci Advisors, LLC |
ir@mediwound.com | daniel@lifesciadvisors.com |
Media Contact: | |
Ellie Hanson |
|
FINN Partners for MediWound | |
ellie.hanson@finnpartners.com | |
+1-929-588-2008 |
MediWound聯繫方式: | |
Hani Luxenburg | Daniel Ferry |
致富金融(臨時代碼) | 董事總經理 |
MediWound Ltd. | LifeSci Advisors,LLC |
ir@mediwound.com | daniel@lifesciadvisors.com |
媒體聯繫人: | |
Ellie Hanson |
|
MediWound的FINN合作伙伴 | |
ellie.hanson@finnpartners.com | |
+1-929-588-2008 |