Dimerix Triggers AU$4.3M Milestone as ACTION3 Phase 3 Trial Launches in Japan

Dimerix Advances Global Clinical Program

Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company focused on inflammatory diseases, has taken a major step forward in its global Phase 3 clinical trial for DMX-200 by activating the first clinical site in Japan. This milestone marks the beginning of patient recruitment in the country and triggers a ¥400 million (approximately AU$4.3 million) development milestone payment from its Japanese licensing partner, FUSO Pharmaceutical Industries Ltd.

The ACTION3 study is a pivotal, multi-centre, randomized, double-blind, placebo-controlled trial evaluating DMX-200 in patients with Focal Segmental Glomerulosclerosis (FSGS), a rare and serious kidney disease characterized by progressive scarring and loss of kidney function. DMX-200 is designed as an adjunct therapy targeting chemokine receptor CCR2 alongside standard angiotensin II receptor blocker treatment, aiming to address the inflammatory component of FSGS.

Strategic Partnership and Regulatory Progress in Japan

The opening of the first clinical site in Japan follows regulatory approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA), ethics committee clearance, and finalization of clinical trial agreements. FUSO Pharmaceutical will take responsibility for clinical development costs, regulatory submissions, and commercialization activities within Japan, while Dimerix retains responsibility for the global ACTION3 trial outside Japan.

This milestone payment underscores the confidence of FUSO in the strength of Dimerix’s clinical data and trial design. It also reflects the broader licensing strategy Dimerix has pursued, with four regional deals collectively offering up to AU$1.4 billion in upfront and milestone payments plus royalties, positioning DMX-200 as a promising candidate in a market with no approved therapies for FSGS.

Implications for Patients and Investors

FSGS is a debilitating disease with limited treatment options, often leading to end-stage kidney disease within a few years. The orphan drug designation granted to DMX-200 in the US and Europe highlights the urgent need for new therapies and offers regulatory incentives that could accelerate approval and market exclusivity.

For investors, the activation of the Japanese site and the associated milestone payment provide tangible validation of Dimerix’s clinical progress and partnership model. The company’s continued focus on trial execution and licensing in other territories suggests further milestones and potential revenue streams ahead.

As recruitment ramps up in Japan and other regions, the coming months will be critical in demonstrating DMX-200’s efficacy and safety profile, which will ultimately determine its commercial viability and impact on the rare kidney disease market.