Angion Enrolls First Patients in Phase 2 Clinical Trial of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia
08/04/2020 | 12:02am EST
SAN FRANCISCO and COVINGTON, Ky., Aug. 04, 2020 (GLOBE NEWSWIRE) -- 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, and CTI Clinical Trial and Consulting Services (CTI), a leading contract research organization, announced enrollment of the first patients in Brazil of 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.
“We’re pleased to enroll the first patients in the trial so soon after initiating the trial,” commented John Neylan, M.D., Angion’s Senior Vice President and Chief Medical Officer. “We worked closely with CTI to commence this study in Brazil, which continues to be tremendously impacted by COVID-19.”
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
“As COVID-19 cases continue to rise in Brazil, the need for accelerated timelines and additional developmental treatment options increases exponentially,” said Tim Schroeder, Founder and CEO of CTI. "The CTI and Angion teams have worked tirelessly to move this program along as quickly as possible without sacrificing safety or quality, and we look forward to the continued progress of the trial.”
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.
Additional details on the Phase 2 clinical trial can be found at ClinicalTrials.gov (NCT #04459676)
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 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.
About CTI Clinical Trial and Consulting Services CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com