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Dimerix Completes Recruitment of First Stage in Phase III Study

Dimerix (DXB: $0.17) has completed recruitment of the first part of its Phase III study in the kidney disease FSGS (focal segmental glomerulosclerosis) with 72 patients. It will now move into the second part where an additional 72 patients will be treated for 35 weeks with placebo or active drug.

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Dimerix (DXB: $0.17) has completed recruitment of the first part of its Phase III study in the kidney disease FSGS (focal segmental glomerulosclerosis) with 72 patients. It will now move into the second part where an additional 72 patients will be treated for 35 weeks with placebo or active drug.

The Phase III study commenced in May this year and is seeking to recruit 286 patients across 70 sites. Interim results from that first cohort can be expected in Q4 this next year.

At last month's AGM, it's worth noting the reference to partnering objectives by the chairman and CEO for the company to 'mitigate capital obligations as well as commercial risk'. A previous deal conducted in FSGS at Phase III is by Travere Therapeutics and Vifor Pharma Group (CSL). In the deal Travere received an upfront payment of US$55 million, with a total deal value of US$845 million plus royalties. Vifor received rights to market the drug, if approved, in Europe, New Zealand and Japan. In its Phase III study in 371 patients with FSGS, a treatment benefit of just 16% was achieved. (i.e. 16% more patients than placebo achieved more than a 40% reduction in their urine protein-creatine ratio.)

Little Benefit Seen in Covid-19 Study
Dimerix also announced the results from its COVID-19 study with DMX-200 in 49 patients. There was little observed benefit in treating patients with the addition of DMX-200 in this study, which was an investigator-led study.

The patient population was heavily treated with other drugs including corticosteroids and 92% were previously vaccinated against the virus.

The main focus for Dimerix is developing DMX-200 for the treatment of kidney diseases. Dimerix is capitalised at $55 million with a proforma cash balance of around $12 million at the end of September.

Bioshares Recommendation: Speculative Buy Class B

 

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