Dimerix Bolsters Kidney Disease Pipeline with Phase 2-Ready AKI Drug DMX-652 Acquisition

Dimerix Acquires First-in-Class AKI Drug Candidate

Clinical-stage biopharma Dimerix Limited (ASX:DXB) has taken a significant step in expanding its kidney disease portfolio by acquiring DMX-652, a Phase 2-ready asset targeting acute kidney injury (AKI). This oral small molecule, designed to inhibit USP30; a mitochondrial enzyme implicated in kidney cell injury; addresses a glaring unmet need: AKI currently has no approved therapies despite its high mortality and morbidity rates.

The acquisition from UK-based Mission Therapeutics includes the composition of matter patent family with protection extending to 2041, an open US Investigational New Drug (IND) application, and an FDA-approved Phase 2 clinical trial protocol. Dimerix also secured sufficient pharmaceutical-grade drug supply and manufacturing know-how to initiate the trial.

Strong Safety Profile and Market Potential

DMX-652’s clinical pedigree includes a Phase 1 trial involving 85 healthy volunteers, where it was well tolerated at single doses up to 200mg and multiple doses of 100mg daily over two weeks, with no serious adverse events linked to the drug. Preclinical data further support its mechanism, which may extend beyond AKI to other renal and non-renal conditions.

Acute kidney injury affects an estimated 100,000 to 133,000 patients annually in the US alone, a population size that may qualify for orphan drug designation. The global market for AKI treatments is forecast to reach US$3.5 billion in 2026, with potential growth to $7.5 billion over the next decade. The initial Phase 2 trial will focus on cardiac surgery-associated AKI, a common and serious complication with no current preventative treatments.

Complementing the Lead Asset DMX-200 in Rare Kidney Disease

This acquisition complements Dimerix’s lead asset, DMX-200, which is in a fully recruited Phase 3 pivotal trial for focal segmental glomerulosclerosis (FSGS), a rare kidney disease characterised by progressive scarring. DMX-652 broadens the company’s renal franchise from chronic glomerular diseases to acute kidney injury, leveraging Dimerix’s existing expertise and global network.

Funding for the DMX-652 Phase 2 trial and completion of the ACTION3 Phase 3 trial for DMX-200 is secured through a combination of existing cash reserves, AU$14 million upfront payment from Everest Medicines for Asian commercial rights, and a AU$10 million loan facility. Negotiations are underway for up to an additional AU$40 million in non-dilutive funding to extend the company’s development runway.

Deal Terms and Upcoming Catalysts

Dimerix paid a US$5 million upfront acquisition fee to Mission Therapeutics, with up to US$287 million in deferred payments tied to clinical milestones, marketing approvals, and sales targets. Royalties range from 8-10% on net sales if commercialised by Dimerix, or 2.5-5% if sublicensed.

The Phase 2 clinical trial is planned as a multicentre, double-blind, placebo-controlled study enrolling approximately 160 high-risk cardiac surgery patients, with dosing expected to commence in the first half of 2027 and interim data anticipated later that year. Success in this trial could significantly diversify Dimerix’s clinical pipeline and provide multiple near- to medium-term value inflection points for shareholders.