Humacyte Acellular Tissue Engineered Vessel (ATEV™) Meets Primary Endpoints in V007 Phase 3 Clinical Trial in Arteriovenous Access for Hemodialysis

Rhea-AI Summary

Humacyte (Nasdaq: HUMA) announced positive top-line results from its V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) for arteriovenous access in hemodialysis patients. The ATEV demonstrated superior function and patency at six and 12 months compared to the current standard of care, autogenous fistula.

Key findings include:

• 81.3% of ATEV patients had functional patency at 6 months vs 66.4% for AV fistula
• 68.3% of ATEV patients had secondary patency at 12 months vs 62.2% for AV fistula
• ATEV patients achieved significantly longer duration of hemodialysis over 12 months

Humacyte plans to discuss potential market authorization with the FDA soon and present detailed results at upcoming medical conferences.

Positive

• ATEV demonstrated superior function and patency compared to standard of care at 6 and 12 months
• 81.3% of ATEV patients had functional patency at 6 months vs 66.4% for AV fistula
• 68.3% of ATEV patients had secondary patency at 12 months vs 62.2% for AV fistula
• ATEV patients achieved significantly longer duration of hemodialysis over 12 months
• Joint test for superiority of ATEV vs AV fistula was statistically significant (p=0.0071)
• ATEV designed to be universally implantable and available off-the-shelf

Negative

• More adverse events reported in ATEV treatment arm compared to AV fistula arm
• ATEV is still an investigational product not yet approved for sale by FDA

Medical Research Analyst

The positive Phase 3 trial results for Humacyte's Acellular Tissue Engineered Vessel (ATEV) represent a significant milestone in the field of hemodialysis access. The ATEV demonstrated superior functional patency at 6 months (81.3% vs 66.4%) and secondary patency at 12 months (68.3% vs 62.2%) compared to the current standard of care, arteriovenous (AV) fistula. This superiority was statistically significant (p=0.0071), indicating a robust clinical benefit.

What's particularly noteworthy is the longer duration of hemodialysis achieved with ATEV over the first 12 months (p=0.0162). This could translate to improved quality of life and potentially better outcomes for patients with end-stage renal disease. However, it's important to note that more adverse events were reported in the ATEV arm, which warrants careful consideration and further analysis.

The potential impact of ATEV is substantial, considering the 808,000 Americans living with end-stage renal disease. Current options like catheters and AV fistulas have significant drawbacks, including high infection rates and failure to function, especially in certain patient populations. ATEV's off-the-shelf availability and potential for lower infection rates could address these unmet needs.

While these results are promising, it's important to await the full data presentation at upcoming medical conferences. The subgroup analysis will be particularly interesting to understand which patient populations might benefit most from this new technology. As we await potential FDA discussions, it's clear that ATEV could represent a significant advance in hemodialysis access, potentially improving outcomes for a large patient population.

Financial Analyst

Humacyte's positive Phase 3 trial results for their ATEV product represent a significant milestone that could substantially impact the company's future prospects. The superiority demonstrated over the current standard of care positions ATEV as a potential game-changer in the hemodialysis access market.

The addressable market is substantial, with 808,000 Americans living with end-stage renal disease. Assuming ATEV gains FDA approval, it could capture a significant portion of this market, potentially driving substantial revenue growth for Humacyte.

Investors should note that the company is still in the clinical stage and commercialization is not immediate. The next critical steps will be discussions with the FDA about a potential market authorization pathway. A smooth regulatory process could accelerate time-to-market and positively impact Humacyte's valuation.

The off-the-shelf nature of ATEV could provide a competitive advantage, potentially reducing healthcare costs and improving accessibility. This could make ATEV attractive to healthcare providers and payers, further driving adoption if approved.

However, the report of more adverse events in the ATEV arm is a point of caution. The nature and severity of these events will be important in determining the overall risk-benefit profile of ATEV and could impact its market potential.

In conclusion, while these results are highly promising and could significantly boost Humacyte's prospects, investors should remain cautious. The company still faces regulatory hurdles and full commercialization is likely some time away. The upcoming detailed results presentation will be important for a more comprehensive assessment of ATEV's potential market impact.

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

– Detailed results to be presented at upcoming medical conferences –

DURHAM, N.C., July 31, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced positive top-line results from the V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) in arteriovenous access for patients with end-stage renal disease. 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.

“We are thrilled to announce positive results for the Phase 3 V007 trial, which we believe highlight the potential of the ATEV to improve AV access in hemodialysis patients who are underserved by the current standard of care,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “Achievement of this major milestone has taken a tremendous amount of effort and commitment from our patients, clinical investigators, employees, and other collaborators, and I thank them for their great support and contributions. We expect to discuss a potential market authorization pathway for the ATEV in hemodialysis access with the Food and Drug Administration soon. We also look forward to presenting more detailed results from the study, including subgroup analysis results, at upcoming medical conferences.”

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 arteriovenous (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, 81.3% of the patients implanted with the ATEV had functional patency compared to 66.4% of the patients receiving an AV fistula. 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 on ATEV also achieved a significantly longer duration of hemodialysis over the first 12 months, as compared to autogenous fistula (p=0.0162). More adverse events were reported in patients on the ATEV treatment arm than those on the AV fistula treatment arm.

Nearly 808,000 Americans are currently living with end-stage renal disease, a medical condition that develops when chronic kidney disease progresses to a point where either dialysis or a kidney transplant is required for survival. Dialysis treatments require establishing a durable point of access to a patient’s circulatory system in order to transfer large volumes of blood to the dialysis machine, and then back into the patient. But the current standard of care for establishing access for hemodialysis has significant risks and shortcomings. Catheters, which are tunneled underneath the skin, have high rates of bloodstream infection, while autogenous AV fistulas often fail to function, particularly for women, forcing patients to rely on infection-prone catheters. In addition, many patients are not suitable candidates for AV fistula placement due to gender, small vessel anatomy, advanced age, obesity, or other comorbidities.

Humacyte’s ATEV is a bioengineered human tissue designed to be a universally implantable vascular conduit for use in vascular replacement and repair, and for use as hemodialysis access. The ATEV has been observed to have a low rate of infection in clinical trials. The ATEV is designed to be available off-the-shelf, and ready whenever surgeons need it, potentially saving valuable operating room time and improving patient outcomes. As announced previously, based on guidance from the FDA, the proper or generic (non-brand) name “acellular tissue engineered vessel” (ATEV) has replaced the term “Human Acellular Vessel” (HAV) that was previously used for our bioengineered vessel candidate.

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. The Company 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 with a PDUFA date of August 10, 2024. 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 expected PDUFA date for our ATEV in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, including our BVP program; the anticipated characteristics and performance of our ATEVs and the BVP; our ability to successfully complete, preclinical and clinical trials for our ATEVs and the BVP; the anticipated benefits of the BVP 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 future 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:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com

FAQ

What were the primary endpoints of Humacyte's V007 Phase 3 Clinical Trial for ATEV (HUMA)?

The primary endpoints were functional patency at 6 months and secondary patency at 12 months, comparing ATEV to autogenous fistula in arteriovenous access for hemodialysis patients.

How did ATEV (HUMA) perform compared to autogenous fistula in the Phase 3 trial?

ATEV demonstrated superior performance, with 81.3% functional patency at 6 months (vs 66.4% for fistula) and 68.3% secondary patency at 12 months (vs 62.2% for fistula).

What is the potential market impact of Humacyte's ATEV (HUMA) for hemodialysis patients?

ATEV could potentially improve AV access for hemodialysis patients, offering a universally implantable, off-the-shelf alternative with superior patency rates compared to current standard of care.

What are the next steps for Humacyte (HUMA) following the positive Phase 3 results for ATEV?

Humacyte plans to discuss potential market authorization pathways with the FDA and present detailed results, including subgroup analyses, at upcoming medical conferences.