Humacyte Announces Presentation of Positive Results from V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology’s Kidney Week 2024
Humacyte (HUMA) presented positive Phase 3 clinical trial results for their ATEV (acellular tissue engineered vessel) in arteriovenous access for hemodialysis patients. The trial demonstrated superior performance compared to standard autogenous fistula, with 81.3% functional patency at 6 months versus 66.4%, and 68.3% secondary patency at 12 months versus 62.2%. Notable improvements were seen in high-risk groups: female patients achieved 8.3 vs 5.0 months of dialysis duration, obese patients 7.7 vs 4.5 months, and diabetic patients 7.4 vs 5.5 months. While infection rates were similar between groups, ATEV showed higher thrombosis rates (52.1% vs 9.1%), though 94% of cases were successfully treated.
Humacyte (HUMA) ha presentato risultati positivi della sperimentazione clinica di Fase 3 per il loro ATEV (vasi ingegnerizzati acellulari) nell'accesso artero-venoso per pazienti in emodialisi. Lo studio ha dimostrato una performance superiore rispetto alla fistola autologa standard, con una patenza funzionale dell'81,3% a 6 mesi contro il 66,4%, e una patenza secondaria del 68,3% a 12 mesi contro il 62,2%. Notevoli miglioramenti sono stati osservati nei gruppi ad alto rischio: le pazienti donne hanno raggiunto 8,3 contro 5,0 mesi di durata della dialisi, i pazienti obesi 7,7 contro 4,5 mesi, e i pazienti diabetici 7,4 contro 5,5 mesi. Sebbene i tassi di infezione fossero simili tra i gruppi, l'ATEV ha mostrato tassi di trombosi più elevati (52,1% contro 9,1%), sebbene il 94% dei casi siano stati trattati con successo.
Humacyte (HUMA) presentó resultados positivos del ensayo clínico de Fase 3 para su ATEV (vaso tejido acelular) en el acceso arteriovenoso para pacientes en hemodiálisis. El ensayo demostró un rendimiento superior en comparación con la fístula autóloga estándar, con una permeabilidad funcional del 81,3% a los 6 meses frente al 66,4%, y una permeabilidad secundaria del 68,3% a los 12 meses frente al 62,2%. Se observaron mejoras notables en grupos de alto riesgo: las pacientes mujeres lograron 8,3 frente a 5,0 meses de duración de hemodiálisis, los pacientes obesos 7,7 frente a 4,5 meses, y los pacientes diabéticos 7,4 frente a 5,5 meses. Aunque las tasas de infección fueron similares entre los grupos, ATEV mostró tasas de trombosis más altas (52,1% frente a 9,1%), aunque el 94% de los casos se trataron con éxito.
Humacyte (HUMA)는 혈액 투석 환자를 위한 혈관 접근에서 ATEV(세포 없는 조직 엔지니어링 혈관)의 3상 임상 시험 긍정적 결과를 발표했습니다. 이 시험은 표준 자가 동맥 문합에 비해 우수한 성능을 입증했으며, 6개월에 81.3%의 기능적 개통율을 보였습니다(66.4% vs 66.4%), 12개월에 68.3%의 이차 개통율(62.2% vs 62.2%)을 보였습니다. 고위험 군에서 주목할 만한 개선이 있었습니다: 여성 환자는 투석 기간에서 8.3개월 대 5.0개월을 기록하였고, 비만 환자는 7.7개월 대 4.5개월, 당뇨병 환자는 7.4개월 대 5.5개월을 기록했습니다. 감염률은 그룹 간 유사했지만, ATEV는 높은 혈전 발생률(52.1% 대 9.1%)을 보였고, 94%의 사례가 성공적으로 치료되었습니다.
Humacyte (HUMA) a présenté des résultats positifs d'un essai clinique de phase 3 pour leur ATEV (vaisseau d'ingénierie tissulaire acellulaire) dans l'accès artério-veineux pour les patients sous hémodialyse. L'essai a démontré une performance supérieure par rapport à la fistule autogène standard, avec une perméabilité fonctionnelle de 81,3 % à 6 mois contre 66,4 %, et une perméabilité secondaire de 68,3 % à 12 mois contre 62,2 %. Des améliorations notables ont été observées dans les groupes à haut risque : les patientes femmes ont atteint 8,3 mois contre 5,0 mois de durée de dialyse, les patients obèses 7,7 mois contre 4,5 mois, et les patients diabétiques 7,4 mois contre 5,5 mois. Bien que les taux d'infection étaient similaires entre les groupes, l'ATEV a montré des taux de thrombose plus élevés (52,1 % contre 9,1 %), bien que 94 % des cas aient été traités avec succès.
Humacyte (HUMA) hat positive Ergebnisse der Phase-3-Studie für ihr ATEV (acellulär gewebte Ingenieurgefäße) im arteriovenösen Zugang für Hämodialysepatienten vorgestellt. Die Studie zeigte eine überlegene Leistung im Vergleich zur Standard-Autograft-Fistel, mit einer funktionalen Patenz von 81,3% nach 6 Monaten im Vergleich zu 66,4% und einer sekundären Patenz von 68,3% nach 12 Monaten im Vergleich zu 62,2%. Auffällige Verbesserungen wurden in Hochrisikogruppen beobachtet: Weibliche Patienten erreichten 8,3 Monate gegenüber 5,0 Monaten Dialysedauer, adipöse Patienten 7,7 Monate gegenüber 4,5 Monaten und diabetische Patienten 7,4 Monate gegenüber 5,5 Monaten. Während die Infektionsraten zwischen den Gruppen ähnlich waren, zeigte ATEV höhere Thromboseraten (52,1% vs. 9,1%), wobei 94% der Fälle erfolgreich behandelt wurden.
- Superior functional patency rates at 6 months (81.3% vs 66.4%)
- Higher secondary patency at 12 months (68.3% vs 62.2%)
- Significantly better outcomes in high-risk patient groups (female, obese, diabetic)
- Statistical significance achieved for primary endpoints (p=0.0071)
- 94% successful treatment rate for thrombosis cases
- Higher rate of thrombosis events in ATEV group (52.1% vs 9.1%)
- More Treatment-Emergent Adverse Events in ATEV group (1,211 vs 828 events)
- Product still requires FDA approval
Insights
The Phase 3 trial results for Humacyte's ATEV represent a significant breakthrough in hemodialysis access treatment. The data shows superior performance with
While the higher thrombosis rate (
These trial results significantly strengthen Humacyte's market position in the
With positive Phase 3 data in hand, Humacyte is well-positioned to pursue FDA approval. The company's commercial-scale manufacturing capability could enable rapid market penetration once approved, particularly given the clear clinical advantages shown in this trial.
– ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access –
- ATEV also showed superior function and patency in female, obese and diabetic patients, subgroups with historically poor outcomes with autogenous fistula procedures -
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.
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. 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.
“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. The significantly higher duration of access over one year in these underserved patients could greatly reduce reliance on catheters for arteriovenous access.”
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. 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,
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). 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). 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).
Rates of infection were low in both treatment arms, with
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Humacyte
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’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. 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. 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.
Forward-Looking Statements
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. 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. 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. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in subsequent SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
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LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
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Precision Strategies
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FAQ
What were the main results of Humacyte's (HUMA) Phase 3 ATEV trial?
How did ATEV perform in high-risk patient groups compared to standard fistula?
What were the safety concerns in Humacyte's ATEV Phase 3 trial?
