ST. GALLEN, Switzerland & UNIONDALE, NY – (BUSINESS WIRE) – 29 Apr 2021–
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Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN), today announced the completion of enrollment for the AKI-002-15 Angion study, the ANG-3777 phase-II trial in patients at risk for acute kidney injury (CSA) related to heart surgery. -BATTERY). This indication is part of the ANG-3777 license agreement signed by the two parties in November 2020.
“CSA-AKI is a frequent complication of heart bypass surgery that occurs in about one-third of patients and is associated with prolonged hospitalization, progressive renal failure, and an increased risk of death,” commented Dr. John Neylan, Senior Vice President and Chief Medical Officer Angion. “At this time, there is no approved therapy to prevent this serious condition. This phase-II preventive trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future ANG-3777 development in a phase-III registration trial for CSA-AKI. We plan to begin confirmatory trials as early as 2022, subject to the results of this phase-II trial as well as discussions with the FDA and other relevant health authorities. “
Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: “We are very pleased that registration for the AKI-002-15 phase-II trial has been completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777 as a potential treatment option for preventing acute kidney injury following cardiac surgery, an indication with an unmet medical need. Together with our partner Angion, we now look forward to assessing the results of the trial. “
Fully enrolled Phase-II trials are randomized, multi-center, double-blind, placebo-controlled clinical trials 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 ANG-3777 or placebo over four days. The first dose is given within four hours after the operation is over with subsequent doses given at 24 hour intervals. The primary endpoint was the mean area under the curve of the percentage increase in serum creatinine above baseline, starting 24 hours after the end of cardiopulmonary bypass surgery to the sixth day. An additional important end point is the occurrence of a Major Adverse Kidney Event at 90 days (MAKE 90), which has previously been approved by the FDA as a suitable primary endpoint for registration trials in this indication. The MAKE 90 “event” was death, initiation of renal replacement therapy or a decrease in eGFR of more than 25% that occurred 90 days after surgery. The AKI-002-15 phase-II trial was designed as a strategic-purpose signaling test to obtain sufficient evidence of the efficacy of ANG-3777 to provide proper strength and evaluate potential enrichment strategies for phase-III registration trials.
ANG-3777 is an investigative 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 significantly longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-class therapy for acute organ injury. Enrollment was completed in a phase-III registration trial in transplant-related acute kidney injury, also known as delayed graft function, a phase II exploratory trial in cardiac surgery-related acute kidney injury, and a phase II exploratory trial in patients with associated acute lung injury. with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a licensing agreement for global rights excluding Greater China to commercialize ANG-3777 in kidney indications with up to $ 1.925 billion in development, commercial and sales achievements 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 a global leader in iron deficiency, nephrology and cardiovascular therapy. The company is the partner of choice for innovative patient-focused medicines and solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better and healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all of its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint venture with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.
Angion is committed to changing the treatment paradigm for patients suffering from acute organ injury and fibrotic disease for whom no approved drug or approved drug has restrictions. Angion’s main product candidate, ANG-3777, is mimetic hepatocyte growth factor (HGF) which is currently being evaluated in a Phase 3 registration trial for delayed graft function in patients undergoing transplantation of a deceased donor kidney, Phase 2 trial on cardiac surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19-associated pneumonia at high risk for acute respiratory distress syndrome. Angion is currently also evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. Additionally, Angion has preclinical programs for rho kinase 2 (ROCK2) inhibitors and CYP11B2 (aldosterone synthase) inhibitors. For more information, please visit www.angion.com.
Angion Forward Looking Statement
The statements contained in this press release regarding matters that may occur in the future are “forward-looking statements” in 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 potential for safety. and the efficacy of ANG-3777, potential outcomes and results of the AKI-002-15 study, and other studies involving ANG-3777 or other candidate products, future clinical trial initiation times and availability and Angion’s disclosure of topline data from those studies. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by those forward-looking statements. In particular, the following factors, among others, could cause the 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 clinical trials of ANG-3777 and other products. candidate; the accuracy of Angion’s estimate with respect to its ability to initiate and / or complete clinical trials; the results of preclinical studies may not predict future outcomes; unpredictable regulatory processes; regulatory developments in the United States, and other foreign countries; clinical trial costs may exceed expectations; Angion’s ability to raise additional capital; effect of COVID-19 on Angion’s clinical programs and business operations. For a description of the risks and uncertainties that could cause actual results to differ from those disclosed in the forward-looking statements, see Angion’s Annual Report on Form 10-K for the year ended 31 December 2020, filed with the Securities and Exchange Commission in March. 30, 2021, as well as other documents that Angion may submit from time to time to the Securities and Exchange Commission. Investors are cautioned against relying too heavily on these forward-looking statements, which only take effect as of this release date. Angion is under no obligation to update any forward-looking statements in this press release, except as required by law.
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KEY WORDS: EUROPE SWISS NORTH AMERICA NORTH AMERICA NEW YORK
INDUSTRY KEYWORDS: CARDIOLOGY RESEARCH, SURGICAL BIOTECHNOLOGY, PHARMACY, HEALTH, CLINICAL TEST
SOURCE: Vifor Pharma
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PUB: 04/29/2021 01:00 AM / DISC: 04/29/2021 01:00 AM