Business Wire

NY-VIFOR

Share
Vifor Pharma and Angion report topline results from phase-III registration trial of ANG-3777 in kidney transplant patients at risk for delayed graft function

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211026006150/en/

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN) today announced that the phase-III trial of Angion’s ANG-3777 did not demonstrate a statistically significant difference from placebo on the primary endpoint (eGFR at 12 months) in the population of deceased donor kidney transplant patients who were at risk for developing DGF.

ANG-3777 showed a modest but not statistically significant difference in eGFR of 53.3mL/min/1.73m2 versus 50.4mL/min/1.73m2 for placebo (2.9 mL/min/1.73m2 (p=0.33)). In addition, ANG-3777 demonstrated an inconsistent benefit on key secondary endpoints. Based upon these data, it is not expected there is sufficient evidence to support an indication in the studied DGF population.

The statistical analysis plan also included an analysis of only those people who completed the trial, without using a multiple imputation method to account for missing data and intercurrent events. Under this analysis, ANG-3777 showed a difference on 12 month eGFR of 57.1mL/min/1.73m2 versus 52.2mL/min/1.73m2 (4.9mL/min/1.73m2 , p=0.06) for placebo. These data are potentially indicative of biologic activity of ANG-3777.

The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and consistent with the published literature in this patient population.

“Unfortunately, the results of the phase-III registrational trial did not confirm as strong of an effect as we hoped for in the interests of patients experiencing DGF after kidney transplantation”, said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “These kinds of challenges are part of clinical development activities. Our collaboration with Angion and the development of ANG-3777 in cardiac-surgery associated acute kidney injury (CSA-AKI) continues unchanged, with topline data expected later this year.”

“We are disappointed in the outcome of this trial. While we saw signals of activity for ANG‑3777, we hoped ANG-3777 would robustly demonstrate a benefit for transplant recipients who have no treatment options when their transplants have DGF,” stated Jay Venkatesan, M.D., Angion’s President and CEO. “The totality of the DGF data, together with the CSA-AKI data expected later this year, will inform our clinical strategy with respect to ANG-3777 going forward. I want to extend my special thanks to the patients, their families, and the investigators and their staff members who participated and worked diligently on this trial.”

This multi-center, double-blinded, and placebo-controlled phase-III trial randomized 253 patients 1:1 to receive ANG-3777 or a placebo treatment dosed once per day for three days. Eligible patients received a deceased donor transplant and were determined to be at risk for delayed graft function by having low urine output (oliguria) for more than 8 consecutive hours post-transplant, reflecting potential graft injury. Twenty-five transplant centers in the U.S. enrolled patients in this phase-III registration trial. The primary endpoint was renal function assessed by estimated glomerular filtration rate (eGFR) with a primary analysis time point of eGFR at twelve months using a pre-specified multiple imputation method.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com .

About Angion

Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic. An exploratory Phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021. Angion is scheduled to begin a Phase 2 trial evaluating ANG-3070, an oral tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in patients with primary proteinuric kidney diseases. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com .

Angion expects to report cash and cash equivalents as of 30 September 2021 totaling approximately $100 million, when it reports quarterly earnings in November 2021.

About ANG-3777

ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF. An exploratory phase-II trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI) is ongoing with data expected in the fourth quarter of 2021. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.

Forward Looking Statements

Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations that release of topline data from the ANG-3777 Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery will be in the fourth quarter of 2021, a global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year, and Angion expects to report cash and cash equivalents as of September 30, 2021 totaling approximately $100 million. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: reporting of trial results or commencing enrollment in clinical trials could be delayed for reasons outside of Angion’s control, including the effects of COVID-19 on Angion’s clinical programs and business operations; and Angion’s September 30, 2021 estimated cash is preliminary and is subject to review and adjustment during the financial review process. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 12, 2021, particularly the information under the caption “Risk Factors,” as well as other documents that may be filed by Angion from time to time with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Cessna Citation CJ3 Gen2 achieves FAA type certification, bringing the most comprehensive Gen2 enhancements to market14.10.2025 00:00:00 CEST | Press release

Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced the Cessna Citation CJ3 Gen2 has achieved Federal Aviation Administration (FAA) type certification, bringing the most comprehensive Citation Gen2 investment to market. Based on customer feedback, enhancements throughout the aircraft include Garmin autothrottle technology, an additional 4.5 inches of legroom for pilots and a fully customizable cabin environment. After completing 445 flight test hours, the light jet is expected to enter into service this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251013311527/en/ Cessna Citation CJ3 Gen2 achieves FAA type certification, bringing the most comprehensive Gen2 enhancements to market (Photo Credit: Textron Aviation). “FAA certification of the CJ3 Gen2 is an example of Textron Aviation’s leadership in certifying aircraft,” said Chris Hearne, senior vice president, Engineering & Programs. “This aircraft de

Cessna Citation M2 Gen2 with Garmin Autothrottles Achieves FAA Certification, Bringing Greater Control and Precision to Pilots14.10.2025 00:00:00 CEST | Press release

The Cessna Citation M2 Gen2 with Garmin Autothrottles recently received certification from the Federal Aviation Administration (FAA), bringing greater control and precision to pilots. The integration of Garmin’s Autothrottle system in the M2 Gen2 further supports the most delivered light-entry jet’s capabilities by optimizing engine power, simplifying flight management and increasing overall operating efficiency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251013861341/en/ Cessna Citation M2 Gen2 with Garmin Autothrottles achieves FAA certification, bringing greater control and precision to pilots (Photo Credit: Textron Aviation). The Cessna Citation M2 Gen2 is designed and produced by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. The flight test program for the Citation M2 Gen2 with autothrottles completed nearly 300 flight test hours and numerous certification tests, adhering to stringent certification stan

HCLTech Delivers Robust Performance in Q2FY26 with Revenue Growth of 4.6%13.10.2025 20:08:00 CEST | Press release

Deal wins at $2.6B; Advanced AI revenue crosses $100m HCLTech, a leading global technology company, reported 4.6% YOY revenue growth in constant currency (CC) for the quarter ended September 30, 2025. USD revenue was at $3.6 billion, up 5.8% YoY. The company revised its Services Revenue growth (CC) guidance to 4%-5%, while retaining the overall revenue and margin guidance for FY26. “We had a standout quarter on every front — marked by strong execution, growing demand for our AI-powered solutions and Advanced AI revenue exceeding $100 million this quarter. Our AI strategy is no longer just a vision; it is now a measurable driver of growth, differentiation and innovation. We are transitioning into an AI monetization phase. For the first time, our new bookings surpassed $2.5 billion, without reliance on any mega deal,” said C Vijayakumar, CEO & Managing Director, HCLTech. HCLTech’s Services revenue grew by 5.5% YoY (CC). Digital revenue was up 15% YoY (CC) and now accounts for 42% of Serv

Cessna Citation Ascend Makes World Debut at NBAA-BACE in Las Vegas13.10.2025 19:00:00 CEST | Press release

The Cessna Citation Ascend landed today at Henderson Executive Airport in Las Vegas, marking its world debut at the 2025 National Business Aviation Association Business Aviation Convention & Exhibition (NBAA-BACE). The aircraft, which flew to the show using sustainable aviation fuel, will be on display Tuesday, October 14 and Wednesday, 15 alongside other industry-leading Cessna Citation business jets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251013102318/en/ Cessna Citation Ascend makes world debut at NBAA-BACE in Las Vegas (Photo Credit: Textron Aviation) The Cessna Citation Ascend is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company. “We asked our customers what they wanted in this iconic aircraft, and our teams worked to bring their vision for the Citation Ascend to life,” said Lannie O’Bannion, senior vice president, Sales & Marketing. “With the aircraft making its debut at NBAA

Power Integrations Details 1250 V and 1700 V PowiGaN Technology for Next-Generation 800 VDC AI Data Centers13.10.2025 17:05:00 CEST | Press release

Company is collaborating with NVIDIA on 800 VDC power architecture; new white paper shows advantages of 1250 V PowiGaN technology vs. 650 V GaN and 1200 V SiC Power Integrations (NASDAQ: POWI), the leader in high-voltage integrated circuits for energy-efficient power conversion, today outlined the benefits of its PowiGaN™ gallium-nitride technology for next-generation AI data centers. The capabilities of 1250 V and 1700 V PowiGaN technology for 800 VDC power architectures are explained in a new white paper from Power Integrations, published at the 2025 OCP Global Summit in San Jose, where NVIDIA provided an update on the 800 VDC architecture. Power Integrations is collaborating with NVIDIA to accelerate the transition to 800 VDC power and megawatt-scale racks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251013503136/en/ Power Integrations details 1250 V and 1700 V PowiGaN technology for next-generation 800 VDC AI data cen

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye