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

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

·          Topline data expected in the second half of 2021

St. Gallen, Switzerland, and Uniondale, NY, 29 April 2021 – 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.