Business Wire

Vifor Pharma and Angion announce completion of enrollment in phase-II study of ANG-3777 for cardiac-surgery associated acute kidney injury

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210428005922/en/

Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN), today announced completion of enrollment for Angion’s AKI-002-15 study, a phase-II trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

“CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death,” commented Dr. John Neylan, Angion’s Senior Vice President and Chief Medical Officer. “Currently, there are no approved therapies to prevent this serious condition. This phase-II prevention trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future development of ANG-3777 in a phase-III registration trial for CSA-AKI. We are planning to start the confirmatory trial early in 2022, subject to the results of this phase-II trial as well as discussions with the FDA and other relevant health authorities.”

Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: “We are excited that enrollment in the AKI-002-15 phase-II trial has completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777as a potential treatment option to prevent acute kidney injury following cardiac surgery, an indication with a high unmet medical need. Together with our partner Angion, we now look forward to assessing the results from the trial.”

The fully enrolled phase-II trial is a randomized, multi-center, double-blind, placebo-controlled clinical trial with trial sites in the United States, Canada, Brazil, and Georgia. Patients at risk for CSA-AKI were randomized one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 or placebo over four days. The first dose was given within four hours of the completion of surgery with subsequent doses given at 24-hour intervals. The primary endpoint is mean area under the curve of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through day six. An additional important endpoint is the occurrence of Major Adverse Kidney Events at 90 days (MAKE 90), which has previously been agreed by the FDA as a suitable primary endpoint for a registration trial in this indication. A MAKE 90 "event" is death, initiation of renal replacement therapy or a greater than 25% decline in eGFR present 90 days after the surgery. The AKI-002-15 phase-II trial was designed as a signal-finding trial with the strategic objective to obtain sufficient evidence of efficacy of ANG-3777 to appropriately power and evaluate potential enrichment strategies for a phase-III registration trial.

About ANG-3777

ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated a substantially longer half-life than HGF and Angion believes ANG‑3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. Enrollment is complete in a phase-III registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a phase-II exploratory trial in cardiac-surgery associated acute kidney injury, and a phase-II exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights excluding Greater China to commercialize ANG-3777 in renal indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceutical 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 currently being evaluating in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. 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 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 regarding the potential safety and efficacy of ANG-3777, the potential results and outcomes of the AKI-002-15 study, and other studies involving ANG-3777 or other product candidates, the timing of the commencement of future clinical trials and the timing of availability of and Angion’s disclosure of topline data from such studies. 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: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of Angion’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; Angion’s ability to raise additional capital; the effects of COVID-19 on Angion’s clinical programs and business operations. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 2021, 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

For Angion:
Daniel Ferry
LifeSci Advisors
617-430-7576
daniel@lifesciadvisors.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

SentinelOne Receives Highest Score for the Type C Use Case in the Gartner 2021 Critical Capabilities for Endpoint Protection Platforms14.5.2021 16:00:00 CEST | Press release

SentinelOne, the autonomous cybersecurity platform company, today announced that Gartner has positioned SentinelOne with the highest score in customer use case C in Gartner’s 2021 Critical Capabilities for Endpoint Protection Platforms report1. SentinelOne also received the highest score across all three Critical Capabilities use cases out of the 19 vendors included in the report. According to Gartner, “Type C organizations typically view technology as an expense or operational necessity and use it as a means to reduce costs.” Additionally, Gartner comments, “For EPP, these organizations focus on prevention, rather than on integrated detection and response capabilities and solutions that offer a complement of managed services.” “Recognition for this use case is a testament to SentinelOne’s ability to offer cost-effective and efficient solutions for enterprises of all types, including those who need to prioritize innovation and capabilities with budget and operational constraints,” said

Wipro Limited Appoints Tulsi Naidu to Its Board14.5.2021 14:22:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced the appointment of Ms. Tulsi Naidu, a widely respected business leader, to its Board of Directors for five years effective July 1, 2021, subject to the approval of shareholders. Tulsi Naidu will serve as an Independent Director on the Board and bring a wealth of experience to Wipro, having spent 25 years in the global financial services sector. Ms. Naidu is CEO Asia Pacific of Zurich Insurance Group (Zurich) and a member of Zurich’s Executive Committee. She joined Zurich in September 2016 and was named the CEO of the UK business in November 2016 where she implemented an extensive transformation program – reshaping the business, simplifying the structure, improving technical and digital capabilities, and positioning it for growth in its core markets. Before joining Zurich, Ms. Naidu spent 14 years at Prudential in various executiv

REPLY: The Board of Directors Approves the Quarterly Report Dated 31 March 202114.5.2021 12:49:00 CEST | Press release

Today, the Board of Directors of Reply S.p.A. [MTA, STAR: REY] approved the results as at 31 March 2021. Since the beginning of the year, the Group has recorded a consolidated turnover amounting to €352.4 million, an increase of 11.2% compared to the corresponding data for 2020. All indicators are positive for the period. In the first quarter of 2021 the consolidated EBITDA was €59.6 million compared to €47.6 million in 2020, equal to 16.9% of the turnover. EBIT, from January to March, was €47.9 million (€38.0 million in 2020), and is equal to 13.6% of the turnover. The profit before tax, from January to March 2021, was €47.6 million (€33.9 million in 2020), equal to 13.5% of the turnover. The net financial position of the Group on 31 March 2021 is also positive by 227.9 million. The net financial position on 31 December 2020 was positive for €158.7 million. “"The first quarter of 2021 - stated Mario Rizzante, Reply's Chairman - was very positive, both in terms of revenue and margin gr

PMC Biogenix Announces Price Increase on Armoslip® and Kemamide® Fatty Amides14.5.2021 11:00:00 CEST | Press release

PMC Biogenix Inc. announces that effective June 1, 2021 or as contracts permit, prices for Armoslip and Kemamide brand primary and secondary fatty amides and bisamides will increase by $1.00 to $3.00 per kilo for all orders, globally; adjusted for currency fluctuations. This increase is necessary to counterbalance the unprecedented and rapid rate of raw material and logistical cost increases and to continue providing the world class service expected by our global customer base. Customers with questions should contact their local sales manager. About PMC PMC Group is a growth oriented, diversified, global chemicals and plastics company dedicated to innovative solutions to everyday needs in a broad range of end markets including plastics, consumer products, electronics, paints, packaging, personal care, food, automotive and pharmaceuticals. The Company was built on a sustainable model of growth through innovation while promoting social good. PMC operates from a global manufacturing, inno

Mavenir Wins Award for Multi-G Open RAN Small Cell Solutions14.5.2021 09:00:00 CEST | Press release

Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, is pleased to announce that it has won the Small Cell Forum Judges’ Choice award for its role in transforming mobile networks through its Multi-G Open RAN small cell solutions and its Mobile Network Operator (MNO) Open RAN neutral host integration. Multi-G Open RAN small cell solutions: Adding 2G/3G across a single unified RAN to support Multi-G radio access in 2020, Mavenir extended its Open Radio Access Network (Open RAN) capabilities across 2G, 3G, 4G and 5G to offer MNOs and enterprises a complete end-to-end, software-centric network proposition, spanning small cell radios to converged packet core to digital enablement solutions. This enables the move towards one network, rather than managing cost and complexity of several different networks. With a seamless, multi radio access technology (Multi-RAT) single RAN solution,

Swimlane and Elastic Partner to Deliver an Extensible Framework for Security Operations Teams13.5.2021 22:30:00 CEST | Press release

Swimlane, provider of the industry's leading security automation platform, and Elastic (NYSE: ESTC), the company behind Elasticsearch and the Elastic Stack, today announced a strategic partnership to help global security teams break down silos in their security processes, and provide a force multiplier to security operations teams that are perpetually overwhelmed. This partnership will enhance existing product integrations and jointly develop new capabilities to help security teams be more efficient and effective in protecting their organizations. The combined power of scale and automation Key integrations will enable even highly distributed security operations teams to significantly reduce friction associated with context-gathering tasks and threat containment — providing critical time savings that help analysts triage alerts quickly while minimizing damage from threats. Swimlane and Elastic plan further enhancements to the product experience through: An extensible framework that exte

IFF Achieves Key 2020 Sustainability Goals13.5.2021 22:15:00 CEST | Press release

IFF (NYSE:IFF) today announced the achievement of key 2020 sustainability goals that were set at the launch of the Company’s sustainability program in 2010. During that time, IFF met and surpassed its original intensity-based targets for three environmental goals, resulting in a reduction in its greenhouse gas (GHG) emissions, water withdrawal and hazardous waste generation per metric ton of production by -42.6%, -67.1% and -41% below 2010 levels, respectively. IFF has also achieved its 2020 goal to have 100% of the palm oil used in its products be certified according to the Roundtable on Sustainable Palm Oil (RSPO) Mass Balance Supply Chain Model. These and other milestones are captured in its latest Sustainability Report, “For a Better World,” which is published today. The title references the Company’s purpose – Applying science and creativity for a better world – a clear and bold aspiration that inspires everyone at IFF to push past traditional boundaries and to be a force for a be