Dimerix Enters into Agreement with Amicus Therapeutics for DMX-200 to Treat FSGS

Dimerix Limited and Amicus Therapeutics have entered an exclusive licensing agreement for the US commercialisation of DMX-200, a Phase 3 investigational treatment for Focal Segmental Glomerulosclerosis (FSGS) and other indications.

DMX-200 is an orally administered CCR2 antagonist given alongside an AT1R blocker, which is standard care in kidney disease and hypertension. The compound is protected by patents through to 2032, with further applications potentially extending coverage to 2042. It also holds Orphan Drug Designation from the FDA in the US.

FSGS is a rare kidney condition marked by scarring in parts of the glomeruli, the filtering units of the kidney. This results in protein loss through the urine, progressive kidney function decline, and often end-stage kidney disease. Inflammation and immune cell activation play key roles in disease progression. The condition affects over 40,000 people in the US, with limited treatment options and high recurrence rates following kidney transplantation, highlighting a significant unmet medical need.

Under the agreement, Amicus will hold exclusive rights to market DMX-200 in the United States, while Dimerix will retain rights for all other global markets not already under exclusive licence.

DMX-200 is a small molecule chemokine receptor 2 (CCR2) inhibitor currently being evaluated in the pivotal Phase 3 ACTION3 trial for patients with FSGS, a rare kidney disease. Interim results from early 2024 indicated a reduction in proteinuria in patients treated with DMX-200, with no significant safety concerns. 

The trial is expected to complete enrolment by the end of 2025. Dimerix recently aligned with the US FDA in a Type C meeting to confirm the use of proteinuria as the primary endpoint for regulatory approval.

Under the terms of the agreement, Dimerix will continue to fund and manage the ongoing ACTION3 study. Amicus will handle the regulatory submissions and all commercial responsibilities in the US. A Joint Steering Committee will be established to coordinate efforts between the two companies.

The agreement also grants Amicus exclusive rights to develop DMX-200 for other potential indications within the country.

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