Benzinga | Jun 29, 2021 04:06PM EDT

Angion Announces Phase 2 ALI-201 Study Did Not Meet Primary Or Secondary Efficacy Endpoint

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 that its exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS) did not meet the primary or secondary efficacy endpoints. The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.



"The ALI-201 study sought to address a patient population severely ill with COVID-19, a multi-system inflammatory condition, which differs markedly from our prior and ongoing clinical trials of ANG-3777 related to transplantation and cardiovascular surgery where the acute kidney injury is a discrete event," stated Dr. John F. Neylan, Angion's Chief Medical Officer. "Patients in the ALI-201 trial had ongoing and accumulating injury from symptomatic COVID-19 on average 11 days before receiving drug with organ systems under continued attack from the SARS-CoV-2 virus. In contrast, patients in our ongoing trials receive ANG-3777 within 1-3 days after the targeted organ injury. COVID-19 is a severe systemic disease presenting significant challenges to both new and previously approved therapeutics."

"We were pleased to be part of the attempt to help patients severely ill with COVID-19 and extend our deepest gratitude to the patients, their families, investigators, and site staff who participated in this study," commented Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "With the increasing availability of approved COVID-19 vaccines and the widespread assumption vaccines will reduce infection rates around the world, we will not continue the development of this COVID-19 program. Based on the promising activity of ANG-3777 in multiple animal models of lung injury, we will continue to evaluate the clinical development of ANG-3777 for acute lung injury populations."

The ALI-201 study was a small exploratory Phase 2 double-blind, randomized, and placebo-controlled trial conducted in Brazil to evaluate the safety and efficacy of four doses of ANG-3777 in 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 ARDS. The primary endpoint of the trial was survival free from the need for mechanical ventilation or dialysis at 28 days. The active arm of the trial did not show a statistically significant difference over the standard of care arm. A total of 120 patients were randomized 1:1 in the trial, with 59 patients in the active treatment arm and 61 patients in the standard of care arm.

The number of adverse events, serious adverse events, and fatal events reported in ALI-201 were slightly higher for those subjects in the active treatment arm compared to those in the standard of care control arm, although no new or unexpected safety signals resulted from the trial. None of the fatal events in this trial of advanced COVID-19 patients were attributed by study investigators to either ANG-3777 or standard of care in the control arm.

The company expects to report data from the ANG-3777 Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021. The company also expects to report data from the ANG-3777 Phase 2 proof of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in the second half of 2021.