Dimerix has taken over sponsorship of a United States investigational new drug application for DMX-652, giving the Australian biotechnology company direct control of clinical development plans for its newly acquired acute kidney injury asset.
The Melbourne-based company said the transfer from UK biotechnology group Mission Therapeutics was complete, allowing Dimerix to become sponsor of the existing US IND and engage directly with the Food and Drug Administration as it prepares for a Phase 2 study.
Dimerix acquired DMX-652 last month as a Phase 2-ready renal program, including the compound’s composition-of-matter patent, manufacturing know-how, sufficient GMP-grade drug supply for the planned trial and an open US IND containing an FDA-approved Phase 2 trial protocol.
The company said it is now targeting the second half of 2026 to begin a Phase 2 clinical trial in acute kidney injury associated with cardiac surgery. The study is intended to assess whether DMX-652 can prevent kidney injury and preserve renal function in high-risk patients.
DMX-652 is a once-daily oral small molecule designed to inhibit USP30, an enzyme involved in mitochondrial quality control. The approach is intended to support the removal of damaged mitochondria in injured kidney cells, a process Dimerix says may be relevant to acute kidney injury caused by reduced blood flow and oxygen supply, toxins or sepsis.
Acute kidney injury remains an area of substantial unmet medical need, particularly among patients undergoing cardiac surgery and those with sepsis. Dimerix estimates the addressable high-risk population across the United States, Germany, France, Italy, Spain and the United Kingdom at about 260,000 patients a year. There are currently no approved therapies specifically for acute kidney injury, which can lead to increased mortality, chronic kidney disease and longer-term renal complications.
Dimerix chief executive and managing director Dr Nina Webster said the IND transfer would allow the company to manage clinical development activities and timelines directly while assessing options to take the program into later-stage development.
She said the asset could have broader potential in diseases associated with mitochondrial dysfunction and may create opportunities for commercial partnerships and additional revenue streams.
The DMX-652 program adds a second renal development asset to Dimerix’s pipeline alongside DMX-200, which is in Phase 3 development for focal segmental glomerulosclerosis, a rare kidney disease marked by progressive scarring of the kidney’s filtering units.
