San Francisco, CA, July 8, 2020 — Angion Biomedica Corp. (Angion), 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, announced it has initiated in Brazil a randomized, placebo-controlled Phase 2 proof-of-concept trial of ANG-3777 plus standard of care in patients with acute lung injury associated with COVID-19 pneumonia.
“Given the potential of ANG-3777 to broadly address acute organ injury, we believe it is important to investigate its ability to mitigate or prevent acute lung injury in patients who have been hospitalized with COVID-19 pneumonia,” commented John Neylan, M.D., Angion’s Senior Vice President and Chief Medical Officer. “We are commencing this study in Brazil, which continues to be tremendously impacted by COVID-19 and where we are conducting another clinical trial of ANG-3777 in patients with acute kidney injury involving cardiopulmonary bypass surgery.”
The Phase 2 trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of ANG-3777 in patients hospitalized with confirmed COVID-19 pneumonia. The primary endpoint of the trial is the proportion of patients alive, without the need for mechanical ventilation and free of the need for renal replacement therapy (on an ongoing basis) at day 28. Angion expects to enroll approximately 100 patients in the trial. Patients will be randomized at a ratio of one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 plus standard of care versus placebo plus standard of care. This ANG-3777 dosing regimen was previously approved for investigational use in Brazil, allowing for a quicker initiation of this trial for a population in need. If the Phase 2 trial is successful in patients with acute lung injury associated with COVID-19 pneumonia, we intend to submit an investigational new drug application (IND) in the United States
“While anti-viral therapies are most welcome in our effort to help patients with COVID-19, front-line physicians need additional tools to address the acute lung injury often seen in these patients,” commented Gregory P. Downey, MD, a pulmonologist at National Jewish Health in Denver, Colorado and a member of Angion’s Scientific Advisory Board. “I’m hopeful data from this trial will show ANG-3777 can be another tool to help address the needs of patients impacted by this pandemic.”
The clinical rationale for this Phase 2 clinical trial of ANG-3777 in patients with acute lung injury associated with COVID-19 pneumonia is rooted in the compelling activity ANG-3777 has shown in several preclinical in vivo models of acute lung injury such as radiation-induced lung injury, chlorine (Cl2)-induced acute lung injury, bleomycin-induced pulmonary edema, TGFβ1-induced mortality and lung fibrosis, lipopolysaccharide (LPS)-induced shock, and lung ischemia-reperfusion injury.
Following the completion of a Phase 2 clinical trial of ANG-3777, Angion is currently conducting a Phase 3 registration trial of ANG-3777 to improve kidney function and reduce the severity of transplant-associated acute kidney injury, also known as delayed graft function, in patients showing evidence of early kidney dysfunction and in a Phase 2 clinical trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass.
Additional details on the Phase 2 clinical trial can be found at ClinicalTrials.gov (NCT #04459676)
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 and we believe ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. The ongoing clinical trials of ANG-3777 include a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a Phase 2 proof-of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery, and a Phase 2 proof-of-concept trial in patients with acute lung injury associated with COVID-19 pneumonia.
About Angion Biomedica Corp.
Angion Biomedica Corp. is 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. Angion’s lead product candidate, ANG-3777, is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the HGF/c-Met pathway, which has a central role in tissue repair and organ recovery. ANG-3777 is currently in clinical trials investigating its impact on acute organ injury, including two forms of acute kidney injury and in acute lung injury. Angion is also developing ANG-3070, an orally-bioavailable small molecule, as a potential treatment for fibrotic diseases using a precision-medicine approach. For further information, please visit www.angion.com.
Source: Angion Biomedica Corp.
Posted: July 2020