Dimerix gains orphan drug nod in Japan for potential rare kidney disease treatment DMX-200

• Dimerix secures orphan drug designation for DMX-200 in Focal Segmental Glomerulosclerosis in Japan
• ACTION3 phase III clinical trial currently recruiting in Japan to support potential marketing approval in country
• FUSO Pharmaceutical Industries has exclusive rights to develop, register and commercialise DMX-200 for treatment of FSGS in Japan

Special Report: Late-stage clinical biotech Dimerix has secured orphan drug designation (ODD) in Japan for its lead asset DMX-200 in Focal Segmental Glomerulosclerosis (FSGS) – a rare kidney disease with limited treatment options and high unmet need.

The designation, granted by the Japanese Ministry of Health, Labour and Welfare (MHLW), provides significant commercial advantages, including 10 years of market exclusivity and pricing premiums.

ODD is a system for supporting and promoting the development of drugs that are not sufficiently researched and developed due to smaller patient numbers.

In Japan, drugs can be designated as orphan drugs if they treat diseases affecting fewer than 50,000 patients and there is a high medical need.

Dimerix (ASX:DXB) also has ODD for DMX-200 to treat FSGS in the US and Europe.

The benefits have the potential to materially strengthen DMX-200’s market position in Japan, one of the world’s largest pharmaceutical markets.

Watch: Dimerix CEO Nina Webster 

‘Urgent need’ for FSGS treatment

DMX-200, a small molecule inhibitor of the chemokine receptor 2 (CCR2), is currently in the pivotal Phase III ACTION3 trial.

To date 243 patients have been randomised/dosed in the ACTION3 clinical trial globally with ~20 to be recruited in Japan.

Positive results could position Dimerix as one of the first companies to deliver an approved therapy for FSGS – a milestone that would validate its pipeline and global strategy.

CEO and managing director Dr Nina Webster said the ODD in Japan reflected the high medical need for DMX-200 as a potential new FSGS treatment in Japan.

“This orphan drug designation reflects the urgent medical need for DMX-200 as a potential new treatment option for patients living with FSGS in Japan,” she said.

“This successful designation is a testament to the expertise and commitment of our commercial partner in Japan, FUSO.”

“With this designation now in place in Japan, as well as in the US and in Europe, we believe we are well positioned to execute on our global strategy to bring patients with FSGS one of the first, if not the first, FSGS treatment, pending success of our phase III trial and subsequent regulatory filings.”

This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.