Dimerix Acquires Phase 2-Ready DMX-652 for Acute Kidney Injury

Australian biotechnology company Dimerix Limited has expanded its kidney disease pipeline through the acquisition of DMX-652, an investigational therapy for acute kidney injury (AKI), from UK-based Mission Therapeutics.

The acquisition adds a Phase 2-ready, first- and best-in-class clinical asset alongside Dimerix’s lead candidate, DMX-200, which is being evaluated in the pivotal ACTION3 Phase 3 trial for focal segmental glomerulosclerosis (FSGS). The deal also provides an active U.S. Investigational New Drug application, an FDA-cleared Phase 2 protocol, manufacturing know-how, GMP drug supply, and patent protection expected through 2041.

A Novel Approach to Acute Kidney Injury

DMX-652 is an investigational once-daily oral small molecule that inhibits USP30, a mitochondrial enzyme involved in mitochondrial quality control. By promoting the removal of damaged mitochondria, the therapy may help protect kidney cells from injury caused by ischemia, sepsis, toxins, and other triggers of AKI. Preclinical studies have shown encouraging efficacy, and Dimerix says the candidate currently has no known clinical-stage competitors.

Acute kidney injury remains a major unmet medical need. It can rapidly impair kidney function, increase the risk of chronic kidney disease, prolong hospitalization, and raise mortality. Despite its clinical burden, no therapies are currently approved specifically for AKI. The addressable U.S. patient population is estimated at 100,000 to 133,000 annually, with the global AKI market projected to reach US$3.5 billion in 2026.

 Phase 2 Program Ready to Advance

DMX-652 enters Dimerix’s portfolio with encouraging early clinical data. In a completed Phase 1 trial involving 85 healthy volunteers, the therapy was well tolerated at single doses up to 200 mg and multiple doses up to 100 mg daily for 14 days, with no treatment-related serious adverse events and a favorable pharmacokinetic profile.

The planned Phase 2 trial will enroll approximately 160 high-risk patients undergoing cardiac surgery in a randomized, double-blind, placebo-controlled study. The primary endpoint is the incidence of AKI seven days after surgery, with additional evaluation of renal function and safety. Ethics approvals and site initiation are expected in the second half of 2026, followed by first-patient dosing in the first half of 2027 and an interim data readout later that year.

Strengthening Dimerix’s Renal Portfolio

The acquisition broadens Dimerix’s focus beyond chronic kidney diseases into acute renal injury while complementing its late-stage DMX-200 program. CEO Dr. Nina Webster said the Phase 2-ready asset expands the company’s renal development strategy, while Mission Therapeutics Executive Director Dr. Anker Lundemose highlighted the significant unmet need in AKI and Dimerix’s expertise in renal drug development. Professor Alexander Zarbock also emphasized the lack of approved therapies for cardiac surgery-associated AKI despite its substantial clinical burden.

Financial Terms and Outlook

Dimerix will pay US$5 million upfront, with additional milestone payments tied to development, regulatory approvals, commercialization, and sales that could exceed US$287 million, plus tiered royalties. The company said existing cash reserves, the anticipated Everest Medicines payment, and available financing are expected to support completion of the ACTION3 Phase 3 trial and initiation of the DMX-652 Phase 2 program.

If future clinical studies confirm its safety and efficacy, DMX-652 could become among the first therapies approved specifically for acute kidney injury. The acquisition strengthens Dimerix’s pipeline across both acute and chronic kidney diseases while positioning the company for multiple clinical and regulatory milestones over the coming years.

Reference

DIMERIX EXPANDS PIPELINE WITH ACQUISITION OF PHASE 2 READY ASSET FOR ACUTE KIDNEY INJURY