Angion's organ damage drug strikes out again, this time in high-risk kidney transplant patients
After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.
Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.
At a 12-week check in, patients treated with ANG-3777 posted an eGFR of 53.3mL/min/1.73m2 compared with 50.4mL/min/1.73m2 in patients dosed with placebo, good for a p-value of 0.33. On top of that “modest” showing, the companies said, ANG-377 posted “inconsistent” results on key secondary endpoints, leading the partners to conclude there’s not much of a path forward here.
“We are disappointed in the outcome of this trial,” Angion CEO Jay Venkatesan said in a statement. “While we saw signals of activity for ANG-3777, we hoped ANG-3777 would robustly demonstrate a benefit for transplant recipients who have no treatment options when their transplants have DGF. The totality of the DGF data, together with the CSA-AKI data expected later this year, will inform our clinical strategy with respect to ANG-3777 going forward.”
It’s an ugly result for Angion and Vifor just months after ANG-3777 flunked a test in severe Covid-19 patients, one of many repurposed drugs that have failed to pass muster during the pandemic.
In July, ANG-3777 missed its primary and secondary endpoints in a Phase II study in severe Covid-19 patients with pneumonia at high risk of developing acute respiratory distress syndrome. The drug was developed as a potential therapeutic for organ damage and fibrotic disease, and Angion hoped to take the drug into the sickest Covid-19 patients at risk of developing ARDS, a condition that compromises patients’ lungs and can prove fatal.
The Phase II ALI-201 study tested four doses of ANG-3777 in 59 Brazilian patients with another 61 receiving standard of care. The trial’s primary endpoint was survival free from the need for mechanical ventilation or dialysis at 28 days. There were more patient deaths in the ANG-3777 arm, Angion said, but those weren’t believed to be tied to the therapy.
At the time, Angion said it still had plans to pursue ANG-3777’s development in acute lung injury given some promising preclinical data, but these latest results could cast doubt on that effort.
The company was trading down more than 55% after hours Tuesday and is currently sitting on $100 million in cash reserves.