Mexico grants key patent for Dimerix’s DMX-652 ahead of Phase 2 trial
Mexico’s Instituto Mexicano de la Propiedad Industrial (IMPI) has granted a composition of matter patent for Dimerix Limited’s (ASX: DXB) Phase 2-ready drug candidate DMX-652, a first and best-in-class USP30 inhibitor targeting acute kidney injury (AKI). The patent, numbered 438406, provides protection until 3 June 2041 and follows a US composition of matter patent granted in July 2026. Mexico’s pharmaceutical market is estimated to exceed US$15 billion, making it Latin America’s second-largest and approximately the twelfth-largest worldwide.
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What this patent means for DMX-652’s commercial position
The strongest form of pharmaceutical IP protection
Composition of matter patents are widely regarded as the gold standard of pharmaceutical intellectual property protection. Unlike method-of-use or formulation patents, they protect the active molecule itself, preventing others from making, using, or selling that molecule in any application.
For DMX-652, this means Dimerix holds protection over the underlying compound, titled “N-cyanopyrrolidines with activity as USP30 inhibitors,” not merely one specific therapeutic use of it. That distinction carries significant weight when it comes to future licensing and partnership discussions.
A growing global IP footprint
The Mexico grant is part of a deliberate strategy to secure robust patent protection across major pharmaceutical markets worldwide. The US composition of matter patent, announced on 23 July 2026, preceded this grant, and together they extend Dimerix’s commercial protection into two significant jurisdictions.
Key details of the Mexico patent:
- Patent number: 438406
- Coverage: Composition of matter protection for DMX-652
- Jurisdiction: Mexico
- Protection until: 3 June 2041
- Prior grant: US composition of matter patent (ASX release 23 July 2026)
Strong patent coverage across major markets directly supports future partnership and licensing negotiations by giving potential counterparties certainty over the commercial exclusivity of the asset.
| Jurisdiction | Patent Type | Patent Number | Coverage | Expiry |
|---|---|---|---|---|
| United States | Composition of matter | Not disclosed in source | DMX-652 active molecule | Not disclosed in source |
| Mexico | Composition of matter | 438406 | DMX-652 active molecule | 3 June 2041 |
Dr Nina Webster, CEO and Managing Director, Dimerix
“The grant of this composition of matter patent in Mexico represents another important milestone in building a strong global intellectual property portfolio around DMX-652. Strong patent protection is fundamental to maximising the value of innovative pharmaceutical assets and is particularly important as we advance DMX-652 toward Phase 2 clinical development. This granted patent further strengthens the long-term commercial opportunity for DMX-652 and supports its commercial attractiveness. We believe DMX-652 has the potential to address significant unmet medical needs in acute kidney injury and potentially other indications where mitochondrial dysfunction plays a key role.”
Understanding AKI — and why DMX-652 could matter
A serious condition with no approved treatments
Acute kidney injury is a severe clinical syndrome characterised by a rapid decline in kidney function, often occurring within hours. It arises most commonly in high-risk settings such as cardiac surgery and sepsis, and is associated with high morbidity and mortality.
There are currently no approved therapies for AKI. The condition is linked to an increased risk of chronic kidney disease and long-term kidney complications, representing a substantial and unaddressed clinical burden. The addressable patient population is estimated at approximately 260,000 per year across the United States, Germany, France, Italy, Spain, and the United Kingdom, a patient population size that may make AKI eligible for orphan drug designation.
How DMX-652 works
DMX-652 is a selective inhibitor of USP30, a mitochondrial enzyme that slows the removal of damaged mitochondria from cells. By inhibiting USP30, DMX-652 is designed to support mitophagy, the natural cellular process by which damaged mitochondria are cleared, promoting cellular recovery in injured kidney cells.
The compound is delivered as an oral, once-daily capsule, a practical format that offers clear advantages in clinical settings. The DMX-652 acquisition package includes an open Investigational New Drug (IND) application in the US, a Phase 2 clinical trial protocol that has received approval to proceed from the US Food and Drug Administration (FDA), and sufficient pharmaceutical-grade (GMP) drug product for the Phase 2 trial.
Phase 2 preparations reinforce the investment case
Preparations for the DMX-652 Phase 2 clinical trial in AKI associated with cardiac surgery are underway, following the acquisition announced on 17 July 2026. Dimerix also has its lead asset, DMX-200, in Phase 3 development for focal segmental glomerulosclerosis (FSGS), giving the company two active kidney disease programmes running concurrently.
The ACTION3 Phase 3 trial completed dosing of its final adult patient with 333 participants randomised, exceeding the original 286-patient target, a level of over-recruitment that strengthens statistical power for the primary endpoint ahead of the March 2028 data readout.
The DMX-652 acquisition, announced on 17 July 2026, was structured at US$5 million upfront against up to US$287 million in potential milestone payments, keeping near-term capital commitments low relative to the total addressable opportunity in a market with no approved therapies.
For investors assessing the DMX-652 opportunity, several material factors are worth noting:
- The Mexican composition of matter patent extends commercial protection to 2041, while the US patent further secures the molecule across all potential applications
- No approved AKI treatments currently exist, representing a significant commercial opportunity if Phase 2 delivers positive results
- An FDA-cleared Phase 2 protocol and sufficient drug supply are already secured, reducing a meaningful portion of development-stage risk
- Mexico’s US$15 billion+ pharmaceutical market adds material commercial territory to the growing IP estate
With IP secured across two major jurisdictions and Phase 2 preparations advancing, Dimerix is building the commercial and clinical foundations to progress DMX-652 toward the next stage of development.
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