More anguish for Angion as safety signal sinks midphase kidney disease trial

The setbacks keep coming at Angion Biomedica. Having failed two clinical trials last year, the biotech has now stopped a third study after identifying a potential safety signal that triggered a reassessment of the risks and benefits of ANG-3070 in patients with established serious kidney disease.

Angion’s losing streak began one year ago, when ANG-3777 failed to move the needle in a phase 2 trial of patients with severe pneumonia related to COVID-19. The bigger hit came in October with the news that the same drug had flunked a phase 3 test in kidney transplant patients. After dropping ANG-3777, Angion identified ANG-3070 as its new lead candidate, moving the therapy into a phase 2 trial in December.

That midphase study came to an abrupt, premature end after the markets closed Wednesday. One of the recipients of the oral tyrosine kinase inhibitor experienced “an unexpected and substantial decline in kidney function,” Angion said, leading the biotech to reassess the risk-benefit profile.   

The review included an analysis of blinded patient data from the phase 2 clinical trial. Angion said the analysis “did not detect any early treatment signal indicating a reduction in proteinuria,” a medical term for increased levels of protein in the urine. The primary endpoint of the clinical trial was the percentage change in 24-hour urinary protein excretion at Week 12.

In the absence of an early efficacy signal, the potential safety concern tipped the risk-benefit balance into unfavorable territory, leading Angion to conclude that stopping the study is in the best interests of patients.

Shares in Angion fell 18% in after-hours trading, dragging the already battered stock down to $1.41. Angion shares traded as high as $25 before the first of the clinical setbacks. 

The termination of the chronic kidney disease clinical trial leaves Angion looking to a phase 1 clinical trial of ANG-3070 in idiopathic pulmonary fibrosis for a boost. Angion expects to release top-line data from the study in the second half of the year, positioning it to enter phase 2 in 2023. 

As with many small biotechs today, questions hang over Angion’s ability to fund development of the drug beyond the near term. Last month, the biotech told investors the $73 million it had at the end of March would fund operations “well into 2023.” Angion’s cash pile is now down to $60 million, and CEO Jay Venkatesan is considering “all strategic and operational options” for the biotech and its pipeline.