Angion Biomedica saw its shares down more than 50% early Wednesday morning on news that its kidney transplant hopeful ANG-3777 has failed a key phase 3 test.
New York-based Angion threw the dice at COVID earlier this year with its anti-fibrotic therapy and came up snake eyes; this was enough to dampen its shares, given that it was more of a punt than a central part of its business.
Now, however, ANG-3777 has failed in a more crucial test: The drug, partnered with Vifor Pharma, failed to hit its primary endpoint after missing statistical significance in the difference, when pitted against placebo in the population of deceased donor kidney transplant patients who were at risk for developing delayed graft function (DGF).
A surrogate biomarker, known as estimated glomerular filtration rate (eGFR), is supposed to help assess how well the kidneys are doing. Going into the details, the biotech said that ANG-3777 “showed a modest but not statistically significant difference” in eGFR of 53.3mL/min/1.73m2 versus 50.4mL/min/1.73m2 for placebo (2.9 mL/min/1.73m2, where p=0.33, a major statistical miss).
It also showed an “inconsistent benefit on key secondary endpoints.” Angion, to its credit, was upfront and honest about the failure, and said that, based upon these data, “it is not expected there is sufficient evidence to support an indication in the studied DGF population.”
Though now considering walking away from DGF, the partnership with Vifor for the drug will definitely continue on in cardiac-surgery associated acute kidney injury, with top-line data in this setting expected later this year.
“We are disappointed in the outcome of this trial. 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,” stated Jay Venkatesan, M.D., Angion’s president and CEO.
“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.”
Shares in Angion were down 56% in premarket trading Wednesday.