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



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

Northleaf Expands Business Development Team With the Addition of Chris O’Connor as a Managing Director for Australia and New Zealand5.8.2021 02:00:00 CEST | Press release

Northleaf Capital Partners (Northleaf) is pleased to announce the appointment of Chris O’Connor as Managing Director, Business Development, Australia and New Zealand. In this new role, Chris will lead Northleaf’s business development and investor relations activities and further develop relationships with institutional investors, consultants and advisors in the region. Chris joins Northleaf’s existing Melbourne-based investment team, extending the firm’s ongoing commitment to private markets activities in Australia and New Zealand. “We are thrilled to welcome Chris to the Northleaf team as our first Australia-based business development executive,” said Jeff Pentland, Managing Director and Head of Business Development at Northleaf. “Chris brings expertise in both relationship building and consultative fundraising, enhancing our capabilities to provide investors with access to highly differentiated mid-market infrastructure, private equity and private credit investments globally.” Prior

Australian Small Businesses Need Greater Access to Finance, According to Taulia5.8.2021 00:00:00 CEST | Press release

Small businesses in Australia continue to unnecessarily struggle when accessing affordable finance and deserve greater options, according to Taulia, the leading fintech provider of working capital solutions. In a new paper, Taulia has outlined the multiple challenges facing Australian small businesses - who often act as suppliers to large local and international businesses - regarding access to finance. Small businesses are the driving force behind Australia’s economy, accounting for 35% of GDP and 44% of employment, but the Reserve Bank of Australia’s analysis of the COVID-19 pandemic shows that lending to these smaller firms has been relatively flat since January 2019. Taulia attributes this ongoing lack of finance to five key causes: The long-term challenge small businesses have had in accessing finance, particularly from traditional banking sources Fewer resources within small businesses dedicated to understanding liquidity risk and cash flow, which can mean they only realise their

Rimini Street Announces Fiscal Second Quarter 2021 Financial Results4.8.2021 22:05:00 CEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced results for the second quarter ended June 30, 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005261/en/ Rimini Street Announces Fiscal Second Quarter 2021 Financial Results (Photo: Business Wire) “For the second quarter, we executed well and remain on track to achieve our strategic growth plan of $1 billion in annual revenue by 2026. We achieved record revenue of $91.6 million, up 16.9% year over year and above the high-end of our guidance range. We also ended the quarter with strong year over year billings growth of 44.4%, a gross margin over 62% and an active client count that grew by 22.5%,” stated Seth A. Ravin, Rimini Street co-founder, CEO and chairman of the board. “In addition, our revenue

Western Union Announces Agreement to Sell Western Union Business Solutions to Goldfinch Partners and The Baupost Group for Approximately $910 Million in Cash4.8.2021 22:04:00 CEST | Press release

The Western Union Company (NYSE: WU), a global leader in cross-border, cross-currency money movement and payments, together with Goldfinch Partners, LLC (“Goldfinch”), a private equity firm investing in businesses at the forefront of digital transformation, and The Baupost Group, LLC (“Baupost”), a $31 billion Boston-based investment firm, today announced that they have entered into a definitive agreement, under which a consortium of Goldfinch and Baupost will acquire Western Union Business Solutions for approximately $910 million in cash. Western Union established Western Union Business Solutions following the acquisitions of Custom House in 2009 and Travelex Global Business Payments in 2011. Western Union Business Solutions, which facilitates cross-border, cross-currency payments and foreign exchange solutions for small and medium-sized businesses and other organizations, represented approximately 7% of total Western Union revenue during the last 12 months ended June 30, 2021. “With

Bob Slinn Joins FunPlus Senior Leadership Team as Vice President of Business Development4.8.2021 17:15:00 CEST | Press release

FunPlus, a leading independent mobile game developer and publisher, today announced that Bob Slinn has been appointed as Vice President of Business Development for the company. As a member of the company’s senior leadership team headquartered in Switzerland, Slinn will report to Chief Business Officer Chris Petrovic and be responsible for leading the company’s Western market strategic business development efforts. These efforts will include managing and expanding FunPlus’ growing list of global IP partners and deepening the company’s platform relationships, as well as leading developer relations efforts in support of the company’s ongoing strategic investment and M&A activities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005425/en/ Bob Slinn Joins FunPlus Senior Leadership Team as Vice President of Business Development (Photo: Business Wire) “We’re delighted to welcome Bob to the team in a leadership role that is t

Tigo Energy Unveils Energy Intelligence Platform to Simplify Fleet Management4.8.2021 16:00:00 CEST | Press release

Tigo Energy, Inc., the solar industry’s worldwide leader in Flex MLPE (Module Level Power Electronics), today unveiled its Energy Intelligence (EI) Solution, a comprehensive digital platform designed to optimize the installer experience around commissioning, monitoring, and maintaining fleets of solar installations. For solar installers, operations and maintenance represents a significant and ongoing burden due to the lack of visibility to the module-level information. Tigo EI quickly identifies issues that increase truck rolls, undermine energy output, and undercut the economic success of said installations. EI also delivers the tools to decrease operation and maintenance costs, increase system performance and revenue, and improve the user experience for both installers and customers. The platform also simplifies the commissioning process by providing greater system visibility and information to end installers and EPCs. “Fleet management technology is the next key enabler in renewable

Avex Releases 100% Hemp Cloth T-shirt4.8.2021 16:00:00 CEST | Press release

Avex Entertainment Inc. began limited sales from July 30 of the T-shirts from a Japanese fabric brand "majotae" (pronounced "ma-yo-tah-e") on its official website, using hemp*1, the natural, sustainable material that is gaining attention globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005064/en/ 100% hemp cloth T-shirt made by majotae (Photo: Business Wire) By maximizing the company's knowhow in creating entertainment contents, Avex shares with the world a new concept in sustainability—hemp cloth, which combines both comfort as clothing, and earth-friendly, ecological aspects. Avex is cultivating a brand new field of business that creates moving experiences beyond the field of entertainment. About majotae Majotae is a brand that utilizes modern technology to resurrect the true texture of the hemp cloth that Japanese people have used since ancient times. The greatest feature of "majotae" is its realization of a

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