Dimerix Expands Kidney Pipeline With Phase 2-Ready Acquisition

Dimerix (ASX: DXB) has acquired DMX-652 from Mission Therapeutics for all indications, adding a Phase 2-ready candidate initially focused on preventing acute kidney injury (AKI).

The transaction gives Dimerix ownership and development control of the oral small-molecule therapy, together with an open Investigational New Drug application in the US and an approved Phase 2 trial protocol.

DMX-652 has completed a Phase 1 study involving 85 healthy participants, where 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 reported.

Dimerix estimates the global AKI treatment opportunity at US$3.5 billion in 2026 and says there are currently no approved therapies for the syndrome, which can rapidly impair kidney function and carries high morbidity and mortality.

Kidney Cell Protection

DMX-652 selectively inhibits USP30, a mitochondrial enzyme that slows the removal of damaged mitochondria, with the therapy designed to support quality control in kidney cells injured through oxygen deprivation, toxins, or sepsis.

The acquisition includes the composition-of-matter patent family, manufacturing methodology, and sufficient pharmaceutical-grade drug product for the proposed Phase 2 study, while the patent is anticipated to expire in 2041.

Dimerix plans to initially evaluate the candidate in patients at high risk of AKI following cardiac surgery, where cardiopulmonary bypass and valve procedures can expose kidneys to oxygen deprivation followed by reoxygenation.

Dimerix will pay Mission Therapeutics US$5 million upfront within 30 days, followed by up to US$47m tied to predefined clinical development milestones.

Further potential payments comprise US$40m upon marketing approval, US$25m for approval in a second indication, and up to US$175m linked to sales milestones.

Mission Therapeutics will receive royalties of 8% to 10% on global net sales made by Dimerix or 2.5% to 5% on net sales generated by a third-party sub-licensee.

Phase 2 Study Takes Shape

The proposed multicentre, double-blind, randomised, and placebo-controlled study will assess DMX-652 in about 160 patients at high risk of cardiac surgery-associated AKI.

Its primary endpoint will measure AKI incidence seven days after surgery, with ethics approval and clinical site initiation anticipated during the second half of 2026.

Dimerix expects first-patient dosing in the first half of 2027 and an interim data readout during 2027, subject to recruitment.

The program broadens Dimerix’s renal pipeline beyond glomerular disease and complements DMX-200, which is in the fully recruited ACTION3 Phase 3 trial for focal segmental glomerulosclerosis (FSGS).

Dimerix considers the two programs differentiated across acute and chronic kidney disease, allowing it to apply its existing renal development infrastructure and relationships to both candidates.

‘Substantial Unmet Need’

“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 director Nina Webster added.

Existing cash, an expected A$14m payment from Everest Medicines, and a discretionary A$10m 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$40m of additional non-dilutive funding.