Dimerix to meet with US FDA for new drug guidance
Clinical stage biotechnology company Dimerix Limited (ASX:DXB) has filed a request to the US Food and Drug Administration (FDA) for a pre Investigational New Drug (IND) application meeting in relation to the Development Plan for DMX-200 in Focal Segmental Glomerularsclerosis (FSGS).
Dimerix anticipates its discussion on DMX-200 will be scheduled in late June and will enable receipt of critical planning information from the FDA in Q3 2016.
FSGS is a progressive form of kidney disease, accounting for 2.3% of patients with end-stage renal disease (ESRD).
Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation specifically in the kidneys. It affects more than 26 million people in the United States alone.
Dimerix has been conducting preclinical testing of DMX-200 in models relevant for kidney disease and testing has shown a significant reduction in proteinuria, strongly supporting the potential of DMX-200 to improve the same condition in patients. The company has also commenced a phase II clinical study in patients with chronic kidney disease in Australia (further details below).
DMX-200 is unique in that it 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 USA for hypertension and treatment of diabetic nephropathy in certain patients.
Dimerix will be working closely with the FDA to gain clarity around its US chronic kidney disease program and clinical trial designs, specifically relating to DMX-200.
The FDA encourages entities developing drugs for Orphan Indications, to obtain guidance on the data necessary to warrant IND submission.
As such Dimerix is seek early agreement with the FDA on critical questions which will define the data and the development plans used to register the drug in the US.
“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,” Dimerix Executive Chairman Dr James Williams said.
“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.”
The move comes on the back DMX-200 Phase II trials.
The DMX-200 Phase II Trial
This two-part trial is a single arm, open label study in adult patients with chronic kidney disease (with proteinuria). The primary end points are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants.
Part A is a dose escalation trial recruiting up to 30 patients. All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day. Each patient will commence on 30mg PPG/day and the dose increased each 28 days to a maximum of 240mg/day, or until proteinuria is absent or reduced to a level the clinician considers acceptable.
The Company expects to carry out an interim analysis of the Part A data to confirm the safety of the therapy and observe any biomarker changes on up to 15 patients. It is expected interim data will be available during 2016.
Part B is an expansion study, in which up to 30 patients are recruited on the best dose identified from Part A.
The company expects to review the design of Part B in consultation with the FDA and in light of all data available to the company, prior to commencement of Part B.
These discussions will be in line with the company’s strategy of pursuing registration for an orphan indication in which the sufferers exhibit chronic kidney disease.
The company has achieved orphan designation for Focal Segmental Glomerulosclerosis (FSGS) from the FDA. The trial has commenced at four sites in Melbourne, Australia, and may be expanded into other jurisdictions to meet recruitment targets and regulatory goals.