• Orphan Drug Designation for DMX-200 in Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease
• Provides financial incentives, regulatory assistance, and market exclusivity in Japan
• Dimerix's Phase 3 clinical trial, ACTION3, is currently recruiting patients in Japan

Dimerix Limited, a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to its lead asset, DMX-200, for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare type of kidney disease. DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2), currently in a pivotal Phase 3 study, ACTION3, in FSGS patients. Achieving ODD in Japan marks a major milestone for Dimerix's Phase 3 rare disease program. 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. The designation provides significant benefits for DMX-200, including financial incentives through grants and tax credits, regulatory assistance via priority consultation and review processes, and market advantages with a 10-year market exclusivity period as well as pricing premiums. These benefits collectively enhance the commercial potential of Dimerix's program whilst simultaneously ensuring timely access for FSGS patients with limited treatment options. The Phase 3 study, ACTION3, is a pivotal, multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). The study is currently recruiting patients in Japan, with approximately 20 patients to be recruited to support potential marketing approval in the country. Dimerix's commercial partner in Japan, FUSO Pharmaceutical Industries, Ltd., has exclusive rights to develop, register and commercialise DMX-200 for the treatment of FSGS in Japan.

Dimerix believes it is well positioned to execute on its global strategy to bring patients with FSGS one of the first, if not the first, FSGS treatment, pending success of its Phase 3 trial and subsequent regulatory filings.