Dimerix buys Phase 2-ready AKI drug DMX-652 from Mission Therapeutics for US$5M upfront, plus up to US$292M in milestones. First-patient dosing targeted for H1 2027.
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Dimerix (ASX: DXB) has bought DMX-652 from Mission Therapeutics, picking up a Phase 2-ready candidate for acute kidney injury (AKI) with an open US Investigational New Drug application and an approved trial protocol.
The oral small-molecule therapy targets USP30, a mitochondrial enzyme that slows removal of damaged mitochondria. The idea is to support quality control in kidney cells injured by oxygen deprivation, toxins, or sepsis.
Dimerix will pay US$5 million upfront within 30 days. Milestone payments could reach US$292 million: US$47 million tied to clinical development, US$40 million on marketing approval, US$25 million for a second indication, and up to US$175 million linked to sales. Mission Therapeutics gets royalties of 8% to 10% on global net sales by Dimerix, or 2.5% to 5% on sales from a sub-licensee.
The deal includes the composition-of-matter patent family, manufacturing methodology, and enough pharmaceutical-grade drug product for the proposed Phase 2 study. The patent is expected to expire in 2041.
DMX-652 has completed a Phase 1 study in 85 healthy participants. It was well tolerated at single doses up to 200 milligrams and multiple daily doses up to 100mg over 14 days, with no drug-related serious adverse events.
Dimerix plans to initially test the drug in patients at high risk of AKI after cardiac surgery, where cardiopulmonary bypass and valve procedures can expose kidneys to oxygen deprivation followed by reoxygenation. The proposed multicentre, double-blind, randomised, placebo-controlled study will enroll about 160 patients. The primary endpoint is AKI incidence seven days after surgery.
Ethics approval and clinical site initiation are expected in the second half of 2026. First-patient dosing is targeted for the first half of 2027, with an interim data readout later that year.
Dimerix estimates the global AKI treatment opportunity at US$3.5 billion in 2026. There are currently no approved therapies for the syndrome, which can rapidly impair kidney function and carries high morbidity and mortality.
The program broadens Dimerix's renal pipeline beyond glomerular disease. It complements DMX-200, which is in the fully recruited ACTION3 Phase 3 trial for focal segmental glomerulosclerosis (FSGS).
"There is a substantial unmet need for novel efficacious therapies for acute kidney disease and DMX-652 represents a unique step forward for these patients," Mission Therapeutics executive director Dr Anker Lundemose said.
"Dimerix's deep domain focus in renal disease and their proven operational expertise make them an excellent partner to further the development and commercialisation of this important drug."
"DMX-652 represents an exciting and differentiated novel compound, and the acquisition of a Phase 2-ready program in acute kidney disease represents an important step in executing our strategy to expand our renal pipeline," chief executive officer Nina Webster added.
Existing cash, an expected A$14 million payment from Everest Medicines, and a discretionary A$10 million loan facility will fund completion of the FSGS ACTION3 trial, the DMX-652 upfront payment, and Phase 2 initiation. Dimerix is also in ongoing discussions for up to A$40 million of additional non-dilutive funding.
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