Lowering the approval hurdles in Dimerix's (ASX:DXB) Phase 3 trial is expected to boost the success, value, and appeal of the company's kidney failure therapy, DMX-200, to potential US partners, according to a Feb. 9 note by Euroz Hartleys.
In January, the company said findings from the US Food and Drug Administration-funded Project Parasol showed that reduced protein in urine lowers the risk of kidney disease progression.
Dimerix requested a meeting with the US FDA to agree on the appropriate protein in urine endpoints for DMX-200 in the Action3 Phase 3 trial, which aims to test the medication in patients with focal segmental glomerulosclerosis, a form of kidney disease.
Euroz believes that as the FDA already approved the design of the company's Phase 3, any modifications during the meeting are optional and offer potential upside.
The firm maintained DXB's speculative buy rating and its AU$1.06 price target.
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