DXB announces positive outcome of FDA meeting
A summary of the minutes from a pre-IND meeting held with the Food and Drug Administration (FDA) on the 29th June 2016, released by Dimerix, show that clinical-stage biotech company Dimerix (ASX:DXB) received a positive reception.
The meeting clarified the path of registration for DMX-200 to be used in the treatment of patients with chronic kidney disease (CKD), specifically for the orphan indication of Focal Segmental Glomerular Sclerosis (FSGS) in the USA, for which DXB has already secured orphan designation.
Identified using DXB’s proprietary screening assay, DMX-200 combines two existing drugs, a chemokine receptor CCR2 blocker used for its anti-inflammatory properties, and an angiotensin II type I receptor blocker which is registered in the US for treatment of high blood pressure and diabetic nephropathy, a disease of the kidney.
The meeting with the FDA validated DXB’s patented screening technology, termed Receptor-Heteromer Investigation Technology (Receptor-HIT), as important in understanding new treatments.
Appropriate endpoints for a pivotal Phase III trial in FSGS was also discussed providing DXB with vital information to assist in the design of the likely single pivotal Phase III trial required to secure registration for DMX-200. The FDA confirmed that a substantial change in proteinuria, common in FSGS patients, may be an acceptable endpoint for traditional or accelerated approval.
DXB confirmed with the FDA that angiotensin receptor blockers are standard of care in the treatment of chronic kidney diseases.
One of the components of DMX-200 will be packaged as a standalone therapy for co administration, rather than packaged in combination with other drugs, reducing the costs and complexity of the clinical trial process. This allows for a smaller pivotal trial requiring fewer patients.
The FDA provided further valuable information and advice for DXB to maximise the supporting value of the current Phase II trial to take DMX-200 through to the pivotal Phase III trial.
As an investor it is important to note that there is no guarantee that DMX-200 will pass clinical trials or receive FDA approval, so seek professional financial advice before making an investment decision.
With more than 26 million people suffering from chronic kidney disease in the United States alone, the need for better treatment options persists.