DMX-652 for Acute Kidney Injury Current Status: Phase 2

DMX-652 for acute kidney injury is currently in phase 2 clinical development.

Acute kidney injury (AKI) is a prevalent and severe clinical syndrome with substantial unmet need. It can arise from several high-risk clinical settings, including cardiac surgery and sepsis, and is characterised by a rapid decline in kidney function, often resulting in high morbidity and mortality. The current addressable patient population is estimated to be approximately 260,000 across the major markets of the United States, Germany, France, Italy, Spain and the United Kingdom per annum, making this indication a potential orphan designation. There are currently no approved therapies for AKI, and the condition is associated with an increased risk of chronic kidney disease and long-term kidney complications.

  1. Demirjian S, Bashour CA, Shaw A, et al. Predictive Accuracy of a Perioperative Laboratory Test–Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA 2022;327:956–64. https://doi.org/10.1001/jama.2022.1751.
  2. Hobson C, Ruchi R, Bihorac A. Perioperative Acute Kidney Injury. Crit Care Clin 2017;33:379–96. https://doi.org/10.1016/j.ccc.2016.12.008

DMX-652 in Acute Kidney Injury

DMX-652 is a selective inhibitor of USP30, a mitochondrial enzyme that slows the removal of damaged mitochondria. DMX-652 is a small molecule delivered as a once-daily oral capsule and is designed to support mitochondrial quality control in injured kidney cells, a mechanism implicated in the progression of AKI caused by ischaemia (reduced blood flow and oxygen supply), toxins or sepsis, as well as other renal and non-renal indications. The DMX-652 acquisition includes the composition of matter patent, an open IND in the US with a Phase 2 clinical trial protocol approved by the US Food and Drug Administration (FDA), sufficient GMP-grade drug product for the Phase 2 trial, and all manufacturing methodology. The Phase 2 trial is designed to investigate DMX-652’s potential to prevent kidney injury and preserve renal function.

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