Business Wire

Vifor Pharma and Angion report topline results from phase-II GUARD trial of ANG-3777 in 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/20211209006035/en/

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN) today announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

The GUARD trial was designed as a signal-finding trial with a primary objective determining the feasibility of advancing ANG-3777 into a global phase-III trial based upon activity and safety of ANG-3777 in patients at risk for CSA-AKI, as there are no approved therapies for these patients.

Topline results appear below. P-values noted were not adjusted for multiple comparisons:

  • The primary endpoint was percentage increase in serum creatinine based upon AUC as measured between 24 hours after the end of surgery through day 6, and indicated there was no significant difference in this short-term endpoint between ANG‑3777 and placebo (8.4% vs. 7.3%, p=0.77).
  • The secondary endpoint of MAKE90, which has historically been acceptable to global regulatory agencies as an approvable endpoint, indicated a potential benefit in patients receiving ANG-3777 with fewer patients in the ANG-3777 arm having a MAKE90 event compared to those in the placebo arm (14.7% vs. 21.5%, adjusted odds ratio of 0.60, p=0.155). MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in Estimated Glomerular Filtration Rate (eGFR) present 90 days after the surgery. The GUARD trial was not powered to demonstrate a statistically significant result on this endpoint.
  • The number of patients who experienced a decline in kidney function as measured by a >25% decrease in eGFR at Day 90 was fewer in the group treated with ANG-3777 (5.6% vs. 16.2%, p=0.012). Other secondary endpoints did not show a clinical benefit, including endpoints on MAKE30, the incidence of AKI through Day 6.

The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and comparable to placebo.

“With the results of this trial, we now have a body of data on the efficacy and safety of ANG-3777 in both transplant and surgery-associated kidney injury,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “Together with our partner Angion, we look forward to thoroughly analyze the full data set and to continue exploring the potential of ANG-3777.”

“This is a preliminary data picture from the trial, and we need additional time to analyze the full data set before determining how we might bring ANG-3777 to patients,” stated John Neylan, MD, Angion’s Chief Medical Officer. “I would like to thank the patients, their families, and the investigators and their staff members who participated and worked diligently to make this trial possible.”

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 ANG-3777 is a hepatocyte growth factor (HGF) mimetic. Angion and Vifor Pharma are evaluating the full data set from the Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). Angion is evaluating ANG-3070, a highly-selective, orally-bioavailable tyrosine kinase receptor inhibitor in development for the treatment of fibrotic kidney and lung diseases and currently enrolling an exploratory Phase 2 trial 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.

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. Angion and Vifor Pharma are evaluating the full data set from the phase-II GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). In November 2020, Vifor Pharma and Angion signed a $1.8 billion total potential value license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.

About the GUARD phase-II study

In the GUARD (Guard Against Renal Damage) trial, a total of 275 patients were randomized 1:1 to receive four doses of ANG-3777 or placebo < 4 hours after the completion of cardiac surgery. Patients eligible for the GUARD trial were determined to be at risk for acute kidney injury based upon multiple factors, including age, baseline renal function, and complexity of the surgical procedure. Thirty-one centers in the U.S., Canada, Brazil, and Georgia participated in this exploratory phase-II trial. The primary endpoint was mean AUC of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through Day 6. MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in eGFR. eGFR decline by >25% assessed at 90 days was calculated using the CKD-EPI formula.

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 future analyses of the 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, the potential for a Phase 3 study of ANG-3777 in CSA-AKI, and the the expectation that global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year. 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: analysis 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. For a description of additional risks and uncertainties, see Angion’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 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.

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

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Westmount Realty Capital Recapitalizes 6.1 Million Square-Foot Industrial Portfolio in Chicago and Milwaukee26.1.2022 21:33:00 EET | Press release

Westmount Realty Capital, a privately held, Dallas-based commercial real estate company announced today that it is partnering with a fund managed by the Real Estate Group of Ares Management Corporation, a leading global alternative investment manager, to recapitalize a 51-asset industrial portfolio totaling 6.1 million square feet located in established industrial submarkets of Chicago and Milwaukee. Westmount and Ares acquired the institutional-quality portfolio of logistics, bulk distribution, and last-mile industrial properties from a Partners Group Westmount joint venture. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220126005816/en/ Westmount Realty Capital and Ares Management Corporation recapitalized and acquired an institutional-quality portfolio of logistics, bulk distribution, and last-mile industrial properties totaling 6.1 million square feet located in established industrial submarkets of Chicago and Milwaukee

artnet AG: Artnet Joins New Deutsche Börse ESG Visibility Hub26.1.2022 20:25:00 EET | Press release

Artnet AG, the leading platform for art market data and media, and the global marketplace for fine art online-only sales, is pleased to announce that it has joined the new Deutsche Börse ESG Visibility Hub. Investors increasingly expect transparency from companies with regard to sustainability. A high level of disclosure and comprehensible reporting enables ESG-related data (ESG translates to Environment, Society, Governance) to be included in investment decisions - with the aim of lowering the risks and positive impact of an investment. Artnet AG has been a pioneer within the art market for over 30 years. By engaging with ESG reporting and initiatives, Artnet continues its ethos of spearheading positive change and sustainable business practices. Artnet strives to continuously offer an environment where its employees, customers, and stakeholders can do what they love in a sustainable way. Furthermore, Artnet values its role in assisting clients in engaging with fine art and collectible

VitreaLab, Quantopticon, Luminess Win Big at SPIE Startup Challenge26.1.2022 19:35:00 EET | Press release

Yesterday, at a ceremony during SPIE Photonics West, VitreaLab, with its laser-lit chip focused on the 2D and 3D display market – a technology which enables more power-efficient displays – was announced the winner of the $10,000 top prize at the 12th annual SPIE Startup Challenge. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220126005652/en/ Jonas Zeuner of VitreaLab, center, is joined onstage by Jenoptik's Song Yop Chung, left, and Ralf Kuschnereit, right. (Photo: Business Wire) With cash prizes all provided by Jenoptik, Quantopticon, a designer of simulation software for quantum photonic hardware manufacturers, received $5,000 for second place. Luminess came in third, winning $2,500, with their versatile platform for safer, more sensitive, and more reliable X-ray medical imaging. The SPIE Startup Challenge, which showcases new businesses, products, and technologies that address critical needs with photonics, is supported

ABO - Óskare Capital: Partnership Announcement26.1.2022 17:30:00 EET | Press release

Alpha Blue Ocean (ABO) and Óskare Capital are announcing today the formation of a strategic partnership to collaborate on investment opportunities associated with cannabis plant-based medicines as well as synthetic molecules that target the mammalian Endocannabinoid system (ECS). Both companies recognize that there are also investment opportunities related to products, infrastructure technologies and services which will be part of the associated ecosystem for this sector. With a strong focus in Europe, the teams will work together to identify those companies with the greatest potential to enter global markets. This sector is nascent in Europe and is still in early stages of development on the pharmaceutical side; both companies see this as a “blue ocean” opportunity as the market emerges in the years to come. The partnership is based on biotech, agtech, and life science expertise; track records in the European VC; and strong access to deal flow, all of which will enable the partnership

Staffmark Group Leverages Rimini Street Support for Oracle PeopleSoft Powering Payroll for 35,000 Employees a Week26.1.2022 17:00:00 EET | 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 that Staffmark Group, an award-winning staffing and recruitment firm, continues to leverage Rimini Street to support the company’s PeopleSoft system environment support and maintenance. Since making the switch to Rimini Street, Staffmark has significantly improved the quality, responsiveness and depth of PeopleSoft support available to its internal IT team, enabled faster tax, legal and regulatory updates, and plans to reinvest support cost savings in service offering innovation and enhancements such as AI analysis capabilities and automated job posting functionality for employers and jobseekers – a vital part of its competitive market strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220126005280/en/

Covetrus Taps César França as President, Global Proprietary Brands26.1.2022 17:00:00 EET | Press release

Covetrus® (NASDAQ: CVET), a global leader in animal-health technology and services, today announced the appointment of César França as President, Global Proprietary Brands. França will lead the companywide development and management of Covetrus’ global proprietary brand portfolio, including the current Covetrus, Kruuse, Vi, Roadrunner Pharmacy, and Calibra brands. The company will rely on his vision and expertise to develop categories, build strategic partnerships, and identify external growth opportunities. França brings more than 25 years of leadership and experience in brand development and management, marketing, sales, business development, and general management to Covetrus. “We’re delighted to welcome César to this new and dynamic role,” said Matt Malenfant, Chief Commercial Officer at Covetrus. “César is a positive, trusted leader with a foundational belief in the power of people and brands. He will work closely with our commercial and operations teams to ensure effectiveness an

o9 Solutions Raises $295 Million From Strategic Investors to Continue its Growth Across Industry Verticals & Markets26.1.2022 16:00:00 EET | Press release

o9 Solutions, a leading enterprise AI software platform provider for transforming planning and decision-making speed and quality in companies across industry verticals, today announced that it has received equity investments totaling $295 million from General Atlantic, including BeyondNetZero, its climate investing venture, Generation Investment Management, a pure-play sustainability investment manager, and existing investor KKR. This significant investment will help o9 build on its momentum and accelerate growth for its AI-powered Integrated Business Planning platform it calls the “Digital Brain” across industry verticals and markets. It will also help o9 drive continued innovation in R&D, industry knowledge models and partner ecosystem development that will help companies implement o9’s game-changing platform faster and realize greater value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220126005218/en/ Chakri Gottemukka

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