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– ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access –

–ATEV™在6个月和12个月（共同主要终点）时表现出优于自体瘘管，自体瘘管是目前血液透析治疗的标准–

- ATEV also showed superior function and patency in female, obese and diabetic patients, subgroups with historically poor outcomes with autogenous fistula procedures -

-ATEV在女性、肥胖和糖尿病患者中也显示出优越的功能和通畅性，这些患者在自体瘘管手术中的预后历来较差-

DURHAM, N.C., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of positive results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for patients with end-stage renal disease at the American Society of Nephrology’s (ASN) Kidney Week 2024, the premier nephrology meeting, in San Diego..

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In the Phase 3 trial, the ATEV demonstrated superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula, which is the current standard of care for hemodialysis patients, and also showed superior function and patency in female, obese and diabetic patients, each of which is a high-need subgroup with historically poor outcomes with AV fistula procedures.

在第三阶段试验中，与自体瘘管相比，ATEV在6个月和12个月（共同主要终点）表现出优越的功能和通畅性，自体瘘管是目前血液透析患者的护理标准，并且在女性，肥胖和糖尿病患者中也表现出优越的功能和通畅性，每个患者都是一个高需求的亚组，AV瘘管手术的结果历来较差。

The late-breaking podium presentation, titled “Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access,” was presented on Saturday, October 26, 2024 by Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School.  .

2024年10月26日，星期六，由Mohamad A.Hussain，MD，PhD，RPVI，FAHA，FRCSC，FACS，Brigham and Women's Hospital的血管和血管内外科医生科学家，外科和公共卫生中心的核心教员以及哈佛医学院的外科助理教授主持了题为“Humacyte无细胞组织工程血管与自体动静脉瘘用于血液透析通路的前瞻性随机试验”的最新讲台演讲。。

“These results show that availability of the ATEV, a biologic conduit, could be game changing in improving arteriovenous access in many hemodialysis patients,” said Dr. Hussain. “I was particularly pleased to see positive results in female, obese, and diabetic patients, groups which typically have poor outcomes with autogenous fistula procedures and historically limited treatment alternatives for hemodialysis access.

侯赛因博士说：“这些结果表明，生物导管ATEV的可用性可能会改变许多血液透析患者动静脉通路的游戏规则。”。“我特别高兴地看到女性，肥胖和糖尿病患者取得了积极的结果，这些患者通常在自体瘘管手术中预后不佳，并且历史上血液透析治疗替代方案有限。

The significantly higher duration of access over one year in these underserved patients could greatly reduce reliance on catheters for arteriovenous access.”.

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The V007 Phase 3 trial (NCT03183245) is a prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Enrolled individuals were randomly assigned to receive either the ​​ATEV or an AV fistula for hemodialysis access and are being followed for up to 24 months.

V007 3期临床试验（NCT03183245）是一项针对美国242名血液透析患者的前瞻性多中心随机临床研究。入选的个体被随机分配接受ATEV或AV瘘管进行血液透析，并接受长达24个月的随访。

Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at six months and secondary patency (blood flow through the conduit) at 12 months, as co-primary endpoints. At six months, 81.3% of the patients implanted with the ATEV had functional patency compared to 66.4% of the patients receiving an AV fistula.

根据试验的统计分析计划，主要疗效评估比较了6个月时的功能通畅率（血液透析通路的可用性）和12个月时的次要通畅率（通过导管的血流），作为共同主要终点。在六个月时，81.3%植入ATEV的患者具有功能通畅性，而接受AV瘘的患者为66.4%。

At 12 months, 68.3% of the patients implanted with the ATEV had secondary patency, compared to 62.2% of the patients receiving an AV fistula. The joint test for superiority of the ATEV versus AV fistula at six and 12 months was statistically significant (p=0.0071). Patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months, as compared to AV fistula (p=0.0162)..

在12个月时，68.3%的ATEV植入患者具有继发性通畅，而接受AV瘘的患者为62.2%。在6个月和12个月时，ATEV与AV瘘管优越性的联合测试具有统计学意义（p=0.0071）。与AV瘘管相比，接受ATEV的患者在前12个月的血液透析时间也显着延长（p=0.0162）。。

Sub-group analysis was also performed in patient groups that historically have poor outcomes with AV fistula procedures. In female patients (n=70), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than female patients receiving an AV fistula (p<0.0001). Female patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 8.3 months versus 5.0 months, respectively (p=0.0011).

亚组分析也在历史上AV瘘管手术结果不佳的患者组中进行。在女性患者（n=70）中，植入ATEV的患者的6个月和1年通畅率明显高于接受AV瘘管的女性患者（p<0.0001）。与AV瘘相比，接受ATEV的女性患者在前12个月的血液透析时间也显着延长，分别为8.3个月和5.0个月（p=0.0011）。

In obese patients (body mass index or BMI of at least 30) (n=93), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than diabetic patients receiving an AV fistula (p=0.0001). Obese patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 7.7 months versus 4.5 months, respectively (p=0.0020).

在肥胖患者（体重指数或BMI至少为30）（n=93）中，植入ATEV的患者的6个月和1年通畅率显着高于接受AV瘘的糖尿病患者（p=0.0001）。与AV瘘相比，接受ATEV的肥胖患者在前12个月的血液透析时间也显着延长，分别为7.7个月和4.5个月（p=0.0020）。

In diabetic patients (n=165), patients implanted with the ATEV had significantly higher six-month and one-year patency rates than diabetic patients receiving an AV fistula (p=0.0024). Diabetic patients receiving an ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months compared to AV fistula, 7.4 months versus 5.5 months, respectively (p=0.0155)..

在糖尿病患者（n=165）中，植入ATEV的患者的6个月和1年通畅率显着高于接受AV瘘的糖尿病患者（p=0.0024）。与AV瘘相比，接受ATEV的糖尿病患者在前12个月的血液透析时间也显着延长，分别为7.4个月和5.5个月（p=0.0155）。。

Rates of infection were low in both treatment arms, with 9.1% of patients implanted with the ATEV experiencing access-related infections (12 total events) compared to 9.9% of patients treated with AV fistula (14 total events). Treatment-Emergent Adverse Events (TAEEs) occurred in 98.3% of patients implanted with the ATEV (1,211 total events) compared to 96.7% of patients treated with AV fistula (828 total events).

两个治疗组的感染率都很低，植入ATEV的患者中有9.1%经历了与通路相关的感染（共12次事件），而接受AV瘘管治疗的患者中有9.9%（共14次事件）。98.3%植入ATEV的患者发生治疗紧急不良事件（TAEE）（总事件1211例），而接受AV瘘管治疗的患者发生率为96.7%（总事件828例）。

The largest area of difference in adverse events was in thrombosis, occurring in 52.1% of patients implanted with the ATEV (126 total events) compared to 9.1% of patients treated with AV fistula (12 total events). The majority of ATEV patients with thrombosis, 94%, were successfully treated.   .

不良事件差异最大的领域是血栓形成，52.1%的ATEV患者（126例总事件）发生血栓形成，而9.1%的AV瘘患者（12例总事件）发生血栓形成。大多数ATEV血栓形成患者（94%）成功治疗。。

The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

ATEV是一种研究产品，尚未获得FDA或任何其他监管机构的批准销售。

About Humacyte

关于腐殖酸盐

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions.

Humacyte，Inc.（纳斯达克股票代码：HUMA）正在开发一个颠覆性的生物技术平台，以提供普遍植入的生物工程人体组织，先进的组织构建体和器官系统，旨在改善患者的生活并改变医学实践。Humacyte开发和制造无细胞组织，用于治疗各种疾病，伤害和慢性病。

Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review.

Humacyte最初的候选产品是一系列ATEV，目前正在进行针对多种血管应用的晚期临床试验，包括血管创伤修复，血液透析的动静脉（AV）通路和外周动脉疾病。目前，FDA正在审查ATEV在血管创伤适应症中的生物制剂许可证申请，并获得优先审查。

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation.

冠状动脉旁路移植术，儿科心脏手术，1型糖尿病治疗以及多种新型细胞和组织应用的临床前开发也在进行中。Humacyte用于血液透析AV通路的6mm ATEV是第一个获得FDA再生医学高级治疗（RMAT）指定的候选产品，并且还获得了FDA快速通道指定。

Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com..

Humacyte的6mm ATEV用于肢体血管创伤后的紧急动脉修复和高级PAD也已获得RMAT指定。ATEV被美国国防部长优先指定用于治疗血管创伤。有关更多信息，请访问www.Humacyte.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

本新闻稿包含基于信念和假设以及当前可用信息的前瞻性声明。在某些情况下，您可以通过以下词语来识别前瞻性陈述：“可能”，“将”，“可能”，“将”，“应该”，“期望”，“打算”，“计划”，“预期”，“相信”，“估计”，“预测”，“项目”，“潜在”，“继续”，“正在进行”或这些术语或其他类似术语的否定词，尽管并非所有前瞻性陈述都包含这些词语。

These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.

这些声明涉及风险、不确定性和其他因素，这些因素可能导致实际结果、活动水平、绩效或成就与这些前瞻性声明所表达或暗示的信息存在重大差异。虽然我们相信本新闻稿中的每一项前瞻性声明都有合理的依据，但我们提醒您，这些声明是基于我们目前已知的事实和因素以及我们对未来的预测，对此我们无法确定。

Forward-looking statements in this press release include, but are not limited to, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals.

本新闻稿中的前瞻性声明包括但不限于关于我们临床前和临床试验的开始，时间，进展和结果的声明；我们ATEV的预期特性和性能；我们成功完成ATEV临床前和临床试验的能力；相对于现有替代方案，我们的ATEV的预期收益；我们ATEV的预期商业化以及我们的商业规模制造能力；；以及监管备案、接受和批准的时间或可能性。

We cannot assure you that the forward-looking statements in this p.

我们无法向您保证本页中的前瞻性声明。

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte投资者联系人：Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Humacyte媒体接触：Rich-LuchettePrecision策略+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Source: Humacyte, Inc

资料来源：Humacyte，Inc