NY-VIFOR
27.10.2021 07:02:10 CEST | Business Wire | Press release
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
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 18:52:00 CET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Andersen Global tilføjer samarbejdsfirmaet Pi Advisory13.2.2026 17:23:00 CET | Pressemeddelelse
Andersen Global styrker sine kompetencer i Afrika gennem en samarbejdsaftale med Pi Advisory, et finansielt rådgivningsfirma baseret i Angola og med afdelinger i Mozambique og Portugal. Pi Advisory tilbyder en bred række af ydelser, herunder fuld skatteservice, forretningssupport og outsourcing, finansiel rådgivning samt en bred vifte af selskabsrelaterede ydelser, der hjælper kunder med alt fra etablering af nye virksomhedsenheder til at navigere i lokale skatteregler. Firmaet integrerer principper for miljø-, samfunds- og ledelsesmæssige forhold (ESG) i sin drift, hvilket afspejler dets engagement i en bæredygtig forretningspraksis. "Dette samarbejde styrker vores evne til at støtte kunder med komplekse behov på tværs af jurisdiktioner," udtalte António Amaral Correia, partner hos Pi Advisory. "Gennem vores samarbejde med Andersen Global kan vi levere løsninger, der imødekommer de skiftende krav fra kunder på de portugisisktalende markeder såvel som globalt." Mark L. Vorsatz, global
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 11:15:00 CET | Press release
Partnership Strengthens Volue’s Position as a European Leader in Electrification Technology Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 10:30:00 CET | Press release
Acquisition strengthens ABB’s ability to deliver system-level advisory support at scale to help critical industries manage increasingly complex electrical infrastructures and safeguard energy resilience Enhances ABB’s Electrification Service division offering in power system studies, grid modelling and electrical risk management for data centers, pharmaceuticals and other critical industries Solidifies ABB at the electrical system level, embedding trusted advisory expertise at the point where operational risks, resilience and performance are defined ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential.
EnergyAustralia, Enerven and NHOA Energy Mark Financial Close and Project Launch of the 245 MWh Hallett Battery in South Australia13.2.2026 08:00:00 CET | Press release
The project will support grid stability in the National Electricity Market, strengthening NHOA Energy’s long-term commitment to the Australian market NHOA Energy, global provider of utility-scale energy storage systems, today marked together with EnergyAustralia and Enerven the official project launch of a 245 MWh Battery Energy Storage System (BESS) in Hallett, near the town of Canowie, in South Australia, following the achievement of financial close and the project’s transition into the delivery phase. The milestone was announced today during a project launch ceremony held at the Hallett Power Station, attended by representatives of EnergyAustralia, Enerven, NHOA Energy, government, Traditional Owners and local community stakeholders. Owned and developed by EnergyAustralia, the Hallett BESS is being built alongside the existing Hallett gas-fired power station and represents the first stage of a broader site development. As delivery partner for Stage 1 of the project, NHOA Energy will
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
