Angeion Corp (ANGN) Reports Complete Enrollment in Phase 2 Study of ANG-3777 for Acute Lung Injury in Patients with COVID-19 Associated Pneumonia
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Angion Biomedica Corp. (NASDAQ: ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced completion of enrollment for its ALI-201 study, a Phase 2 trial conducted in Brazil of ANG-3777 for the reduction of severity and progression of acute lung injury in patients with COVID-19 associated pneumonia who are at high risk of progressing to acute respiratory distress syndrome, or ARDS.
To be enrolled in the trial, subjects must have been admitted to the hospital with confirmed COVID-19 disease and either require non-invasive mechanical ventilation or have insufficient blood oxygen saturation while on high flow oxygen administration. The primary endpoint is survival free from the need for mechanical ventilation or dialysis at 28 days. This trial was powered in a manner where only a very substantial improvement in the primary endpoint will result in a statistically significant outcome.
“We have preclinical data from a number of studies indicating ANG-3777 has activity in models of acute lung injury and ARDS,” commented Dr. John Neylan, Angion’s Senior Vice President and Chief Medical Officer. “This exploratory Phase 2 trial was designed to detect signals of activity for ANG-3777 in patients at high risk of ARDS in the context of COVID-19 related pneumonia. While powered only to detect a substantial improvement in the primary endpoint, we will evaluate the totality of the data for signals of efficacy and safety to help guide future development of ANG-3777 in conditions related to acute lung injury and ARDS.”
About ANG-3777ANG-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 placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. Enrollment is ongoing in a Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology 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 AngionAngion 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.
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