MediWound Announces Positive Results From the U.S. NexoBrid Expanded Access Protocol (NEXT)
MediWound Announces Positive Results From the U.S. NexoBrid Expanded Access Protocol (NEXT)
NEXT Confirms NexoBrid's Proven Safety and Efficacy in Eschar Removal, Significantly Reducing Surgical Procedures for Burn Patients
NEXt確認NexoBrid在燙傷患者糜爛去除方面的安全性和療效已得到證實,顯著降低手術風險。
YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid.
以色列雅夫尼,2024年8月5日,環球新聞--MediWound Ltd.(納斯達克:MDWD),生物醫藥領域的全球環境下一代酶類治療方案修復組織的領導者,今天宣佈了「即將推出的擴展訪問計劃」的正面結果。 NEXt旨在確保NexoBrid在商業化之前在燒傷中心中持續可用。這個項目成功地維持了醫生的專業知識,爲燒傷受害者提供了持續使用這種救生特效藥的途徑,促進了NexoBrid在現實世界的安全性和臨床數據的積累。
Jeremy Goverman, MD, FACS, Associate Professor of Surgery at Harvard Medical School, commented, "The NEXT results reaffirm the significant benefits of NexoBrid in managing severe burns. This enzymatic debridement agent accelerates the debridement process and reduces the need for surgical interventions, ultimately enhancing patient outcomes. The findings from NEXT are consistent with data from the DETECT and CIDS Phase III trials, reinforcing the critical role that NexoBrid should play in standard burn care protocols."
哈佛醫學院外科副教授Jeremy Goverman MD,FACS評論道:「NEXt的結果證實了在處理嚴重燒傷中NexoBrid的顯著益處。這種酶解除對治療過程進行了加速和降低手術干預的需求,最終提高了患者的預後。 NEXt的發現與DETECt和CIDS三期試驗的數據一致,強調了NexoBrid在標準燒傷護理方案中應該扮演的關鍵角色。」
NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid.
NEXt是一個開放標記、單臂治療方案,在美國的29個燒傷中心進行。包括215名成年人和24名兒童在內的239名患有深部部分和全層燒傷,覆蓋總身體表面積(TBSA)高達30%的患者接受了NexoBrid的治療。
Key Results of the NEXT Protocol Include:
NEXt方案的關鍵結果包括:
-
Efficacy (findings were consistent with Phase III studies results):
- 94.9% of adults and 100% of children achieved complete debridement.
- Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group.
- The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children.
- The time to complete eschar removal was less than one day for both adults and children.
-
Healing and Hospitalization:
- The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children.
- The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children.
- Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB).
- Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable.
- 療效(結果與三期研究一致):
- 94.9%的成年人和100%的兒童達到了完全糜爛去除。
- 僅有4.2%的成年人需要進行手術切除糜爛去除,兒童組中沒有患者接受手術治療。
- 成年人外科手術切除切口面積的均值(±標準偏差)爲3.6%(±18.33),兒童爲0%。
- 糜爛去除完成時間不到一天,成人和兒童都很快。
- 癒合和住院:
- 成人的中位癒合時間爲22天(95%CI:22、23),兒童爲28天(95%CI:18、32)。
- 成人的中位住院時間爲10天(95%CI:8、11),兒童爲10天(95%CI:5、14)。
- 安全性:NexoBrid的安全性與已確認的安全數據一致,數據安全監測委員會(DSMB)沒有發現新的安全問題。
- 效益-風險比:NexoBrid治療的整體受益-風險比仍然是有利的。
About NexoBrid
關於NexoBrid
NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories.
NexoBrid是一種局部應用的生物製品,通過酶降解的方式治療患有深部部分和/或全層熱性燒傷的患者,去除不可行的燒傷組織或糜爛,而不會對生存的組織造成損害。NexoBrid已在40多個國家得到批准,包括美國、歐盟和日本。所有這些地區都將其指定爲孤兒生物製品藥物。
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.
NexoBrid的開發已在美國衛生與公衆服務部獲得全額或部分資助。戰略準備和反應行政機構;在HHSO100201500035C合同根據生物醫藥先進研究和發展當局(BARDA)的批准下,該協議爲關鍵的美國三期臨床研究DETECT、用於兒童的隨機對照關鍵臨床試驗CIDS提供了資金和技術支持,以及NexoBrid的營銷批准註冊過程,以及其在即將推出的擴展訪問協議(NEXT)下的採購和供應。在BARDA合同資助的NexoBrid評估的其他項目包括建立預使用數據包和開展健康經濟模型,以評估成本節約對未來市場採納的影響。
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。
For more information visit and follow the Company on LinkedIn.
獲取更多信息,請訪問並在社交媒體上關注公司。LinkedIn.
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, 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 our expectations regarding future growth, market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; 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警告您,除了本新聞稿中包含的歷史事實陳述之外,所有其他陳述都是前瞻性陳述,涉及到我們預計、認爲或預期的將或可能發生的未來活動、事件或發展。雖然我們認爲本新聞稿中所含的前瞻性陳述具有合理的依據,但它們基於我們當前對未來影響我們的事件的期望,並且受到風險、假設、不確定性和因素的限制,這些因素難以預測,並且其中許多因素超出我們的控制範圍。本新聞稿中所包含的前瞻性陳述通常使用諸如「預計」、「計劃」、「估計」、「計劃」、「期望」、「繼續」、「相信」、「指導」、「展望」、「目標」和類似詞或短語、或者像「將」、「會」、「應該」、「能夠」、「可能」或類似表達未來或條件性動詞。具體而言,本新聞稿包含關於我們的產品和產品候選品,包括NexoBrid的預計進展、發展、期望和商業潛力的前瞻性陳述。導致結果與本新聞稿中所述結果實質性不同的因素包括我們預期的未來增長、市場對我們的產品和產品候選品的接受程度;我們保護知識產權的能力;競爭風險;政府法律和法規的影響以及當前全球宏觀經濟形勢對我們未來運營所需的供應品採購或生產、銷售和支持我們未來的產品和產品候選品的能力或能力的影響。所有這些主要因素的更多詳細信息將在MediWound 2023年12月31日報告的20-F年度報告、於2024年3月21日提交給證券交易委員會的6-K季度報告及其他日常提交給證券交易委員會的文件中進行更詳細的討論. 這些前瞻性陳述反映MediWound目前的看法,並於此發佈日期發表。MediWound承擔專門否認的義務更新任何這些前瞻性陳述,以反映這些的相關意見或後來發生的事件或情況,除法律另有規定外。
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 |