Dimerix (DXB: $0.36) has enrolled more than the target 286 patients into its Phase III FSGS orphan kidney disease study. A total of 333 adult patients have been recruited and initiated treatment. Patients will be treated for two years, with each patient given the option to continue in an open label extension study on DMX-200.
The last patient will finish treatment in March 2028. The company is now in a position to conduct a blinded review, and then potentially an unblinded review on 35 week treatment data from the first 144 patients. However alignment needs to be achieved with the FDA first, as well as advice following the blinded review from the Data Monitoring Committee.
It has taken just under three years to complete recruitment, which was conducted at 219 sites and 21 countries. It has been an excellent achievement.
The FSGS addressable market in the US is estimated at US$430 million a year (incidence 7 in 1 million, cost of treatment US$15,000 per month).
Dimerix finished December with $38.5 million, with sufficient funding for just under 12 months on its most recent spend.
Bioshares recommendation: Speculative Buy Class A
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