NY-VIFOR
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211026006150/en/
Link:
About Business Wire
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
Verimatrix: Signing of an Agreement for the Sale of XTD Assets (Code and Application Protection) to Guardsquare8.12.2025 17:45:00 CET | Press release
Sale of XTD assets (mobile application protection) including a portfolio of patents and a team of experts for an initial offer of $8.5m, the final price will be adjusted at the closing.Verimatrix refocuses on Anti-Piracy (video protection), the group's core business representing approximately 90% of its total revenue Regulatory News: VERIMATRIX (Euronext Paris: VMX, FR0010291245), a leading provider of user security solutions for a safer connected world, announces the signing of an agreement with Belgium-based Guardsquare, the leading provider of mobile application security, for the sale of its Extended Threat Defense (XTD) assets. Guardsquare, the creators of the open-source optimization tool, ProGuard, offers the most complete mobile application security platform on the market spanning automated testing and multi-layered protection, real time threat monitoring, and app attestation. Guardsquare’s 975+ customers are located in more than 95 countries and represent all major industries.
WNBA Champion Sabrina Ionescu Becomes Global Brand Ambassador for Ant International8.12.2025 17:00:00 CET | Press release
Four-time WNBA All-Star Sabrina Ionescu today becomes a new Global Brand Ambassador for Ant International, a leading global provider of digital payments, digitisation, and financial technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208536426/en/ The partnership is built on a shared commitment to creating a more inclusive and sustainable world through empowering underserved communities and youth groups with sports and technology innovation. It marks an important step in Ant International’s journey to foster growth and expand access to financial tools through innovative technology. Ionescu serves as the first Ant International global brand ambassador from North America. “Sabrina embodies the spirit of perseverance and the passion for excellence that is driving young talents and small businesses around the world to uplift their communities,” said Douglas Feagin, President of Ant International. “As a legend in a spor
SABCS 2025: REVEAL GENOMICS Presents Major Advance in Predicting Brain Metastasis in HER2+ Breast Cancer8.12.2025 16:20:00 CET | Press release
The new HER2DX central nervous system (CNS) progression score predicts risk of brain progression in advanced HER2+ breast cancer, addressing a major unmet need in identifying patients at the highest risk of CNS involvement. During SABCS 2025, the company presents a total of 7 studies with 1,300 tumor samples analyzed, covering HER2-positive, ER-negative, and triple-negative breast cancer (TNBC), representing one of the largest and most comprehensive genomic data contributions to the symposium. New clinical evidence includes superior pCR prediction compared with TILs, demonstration of real-time genomic testing feasibility in an international trial, and validation of RNA-based ERBB2 assessment to accelerate clinical decision-making. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology company focused on advancing precision oncology through biomarker innovation, announced today the presentation of seven studies at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025, held Decem
NetApp Advances EMEA & LATAM Presence with Appointment of Willem Hendrickx as Customer Demand for AI Accelerates8.12.2025 16:15:00 CET | Press release
A leader in driving enterprise transformation, Hendrickx brings nearly three decades of experience, strengthening global partner ecosystems and customer relationships across regions NetApp (NASDAQ: NTAP), the intelligent data infrastructure company, today announced the appointment of Willem Hendrickxas Senior Vice President and General Manager, EMEA & LATAM, effective January 5, 2026. Hendrickxwill lead NetApp’s business strategy, go-to-market execution, and partner engagement across Europe, the Middle East, Africa, and Latin America. Reporting to NetApp President César Cernuda, Hendrickx brings a deep regional knowledge and track record of building high-performing teams, further enabling the acceleration of NetApp’s international footprint by helping global customers navigate the evolving demands of hybrid cloud and AI-driven data infrastructure. Hendrickx holds a Master’s degree in Applied Economics from KU Leuven and is based in Brussels, Belgium. “Willem joins NetApp at a pivotal t
MediaKind and Harmonic’s Video Business to Combine, Creating a Leading Streaming-Infrastructure Platform8.12.2025 15:37:00 CET | Press release
Combined business will be the #1 independent comprehensive streaming-infrastructure platformBrings together complementary product teams to drive faster advancement across cloud and appliance technologiesFurthers MediaKind’s mission to redefine the future of media and entertainment through advanced video technology MediaKind, a global leader in cloud-based video streaming technology, today announced it has entered into an agreement to acquire the Video Business of Harmonic Inc. (NASDAQ: HLIT) for approximately $145 million. Following a French employee works council consultation process, the parties would immediately execute a purchase agreement, and the transaction would be expected to close in the first half of 2026, subject to customary regulatory approvals and closing conditions. The transaction creates a world-class independent SaaS streaming infrastructure provider by combining two established video technology organizations with complementary strengths in SaaS streaming, appliance
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
