Dimerix Limited has received a significant milestone payment from its Japanese partner FUSO Pharmaceutical, marking progress in the Phase 3 clinical trial of DMX-200 for kidney disease. This payment underscores the growing momentum behind Dimerix’s global licensing strategy.
- First development milestone payment of ¥400 million (~AU$4.2 million) received from FUSO
- Clinical sites opened in Japan to support ACTION3 Phase 3 trial recruitment
- FUSO licensing deal is one of four regional agreements for DMX-200
- Potential total milestone payments and royalties from FUSO could reach ~AU$107 million
- Collective licensing deals may deliver up to ~AU$1.4 billion plus royalties globally
Milestone Payment Signals Clinical Progress
Dimerix Limited (ASX, DXB), a clinical-stage biopharmaceutical company focused on kidney disease, has announced receipt of its first development milestone payment of approximately AU$4.2 million from FUSO Pharmaceutical Industries Ltd. This payment follows the opening of clinical trial sites in Japan for the pivotal Phase 3 ACTION3 study evaluating DMX-200 in patients with Focal Segmental Glomerulosclerosis (FSGS), a rare and serious kidney disorder.
The milestone payment reflects a key step in advancing DMX-200’s clinical development and commercialisation in Japan, where FUSO holds exclusive licensing rights. The ACTION3 trial aims to recruit around 20 patients in Japan to support potential regulatory approval, complementing ongoing global efforts.
Robust Licensing Strategy Across Multiple Territories
This milestone is part of a broader licensing framework that includes four regional deals for DMX-200, collectively positioning Dimerix to receive up to AU$1.4 billion in upfront and milestone payments, plus royalties on net sales. The FUSO agreement alone could yield up to AU$107 million in payments and 15-20% royalties, contingent on clinical and commercial success.
Dimerix has already received over AU$65 million from these licensing arrangements, underscoring strong partner confidence. The company continues to explore additional licensing opportunities in unlicensed territories, including China, aiming to expand DMX-200’s global footprint.
DMX-200 and the Urgent Need for New FSGS Treatments
DMX-200 is a novel chemokine receptor antagonist designed to complement standard care in FSGS patients, a condition with limited treatment options and a high risk of progression to end-stage kidney disease. The Phase 3 ACTION3 trial is a randomized, placebo-controlled study designed to generate robust evidence on DMX-200’s efficacy and safety, with interim analyses planned to support regulatory submissions.
With granted patents protecting DMX-200 until at least 2032 and orphan drug designation in the US, Dimerix is well positioned to address this unmet medical need. The recent milestone payment and clinical progress represent important validation points for investors and stakeholders.
Bottom Line?
Dimerix’s milestone payment from FUSO marks a pivotal step in DMX-200’s journey, but upcoming trial results will be critical to unlocking further value.
Questions in the middle?
- How quickly will patient recruitment in Japan progress following site openings?
- What are the timelines and likelihood for achieving the next development and sales milestones?
- Could additional licensing deals in China or other regions significantly alter Dimerix’s revenue outlook?