Angion Biomedica Corp. (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today announced the discontinuation of JUNIPER, its Phase 2 dose-finding trial of ANG-3070, an oral tyrosine kinase inhibitor (TKI), in patients with primary proteinuric kidney diseases, specifically focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN). This trial, which began enrolling patients in December 2021, is being discontinued in the interest of patient safety based upon a reassessment of the risk/benefit profile of ANG-3070 in patients with established serious kidney disease.
This reassessment was conducted following the occurrence of a potential safety signal of an unexpected and substantial decline in kidney function in a patient in the trial’s drug treatment arm and took into account a number of factors, including an evaluation of the totality of the data Angion has reviewed with respect to ANG-3070, known TKI class side effects, including potential adverse effects on the kidney, and an analysis of the blinded patient data which did not detect any early treatment signal indicating a reduction in proteinuria. These factors collectively lead Angion to believe discontinuation of the JUNIPER study is in the best interest of patients. Angion is communicating with clinical trial sites and regulatory authorities regarding its decision to terminate the trial.
https://finance.yahoo.com/news/angion-announces-discontinuation-phase-2-200500227.html
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