Dimerix (ASX:DXB), a clinical-stage biotechnology company focussed on discovering and developing new therapeutic treatments identified using its proprietary screening assay, has announced that it has filed a request to the US FDA for a pre-Investigational New Drug (IND) application meeting in relation to the Development Plan for DMX-200 in Focal Segmental Glomerularsclerosis (FSGS).
This event triggers conversion of 75,000,040 Class B Performance Shares to ordinary shares, said the company.
FSGS is a chronic kidney disease, for which Dimerix’s DMX-200 has received orphan drug designation.
Dimerix said it anticipates its discussion on DMX-200 will be scheduled in late June and this will enable receipt of critical planning information from the FDA in Q3 2016.
DMX-200 combines two existing drugs, a chemokine receptor CCR2 blocker (propagermanium) used for its anti-inflammatory properties, and an angiotensin II type I receptor blocker (irbesartan) which is registered in the US for hypertension and treatment of diabetic nephropathy in certain patients.
According to the company, preclinical testing of DMX-200 in models relevant for kidney disease showed a significant reduction in proteinuria, strongly supporting the potential of DMX-200 to improve the same condition in patients.
Dimerix Executive Chairman Dr James Williams said: “Discussing DMX-200 with the FDA will provide us with valuable clarity around our US chronic kidney disease program and clinical trial designs, and the nonclinical package which the FDA will require for each development stage, including ultimate registration requirements of DMX-200 for FSGS. This information should place Dimerix in a strong position to map out the registration pathway and is a critical step towards realising the commercial value of our lead asset DMX-200.”