The study was slow in recruiting initially, with the study starting in February although recruitment numbers began to accelerate last month. The first 72 patients are expected to be recruited this year with interim results mid next year, which will be a major milestone.
One of the reasons recruitment is accelerating is because recruitment into the Phase III study with the drug candidate sparsantan, also in FSGS, has completed. Sparsantan is being developed by Travere Therapeutics with Vifor Pharma Group (now CSL) having accessed rights to Europe, Australian and New Zealand last year. The deal included a US$55 million upfront payment with US$135 million and a royalty rate of up to 40%.
Travere was seeking to recruit 371 patients into its Phase III FSGS study. Sparsantan blocks two pathways (endothelin type A and angiotensin II type 1 (AT1R)). The compound is not necessarily a direct competitor to Dimerix's DMX200, with the Travere trial comparing sparsantan with another AT1R inhibitor, irbesartan. DMX200 is expected to be synergistic with all AT1R inhibitors.
Travere recently received feedback from the FDA that its application for accelerated approval was declined as the interim results did not meet the threshold set by the regulator. After 36 weeks of treatment, its proteinurea result (measured as more than a 40% reduction from baseline in the urine protein-to-creatine ratio) was achieved in 42% of patients compared to 26% of patients receiving irbesartan, a 16% benefit.
In Dimerix's Phase II study in FSGS, 29% of patients receiving DMX200 (plus an AT1R as background therapy) achieved a drop of more than 40% in proteinurea levels compared to backgound therapy alone. However, this outcome may have also been hindered by the crossover nature of the study, with those taking DMX200 first possibly having a disease modifying effect when switched to placebo and not returning to baseline.
The second analysis of the Dimerix Phase III study will occur once 144 patients have reached the 35-week treatment point. If results are positive, the company will seek to file the drug for accelerated approval with the FDA. It will continue to recruit the remaining patients, with final analysis being the measure of kidney health eGFR (filtration rate).
Study in Diabetic Kidney Disease to Start
Towards the end of this year, Dimerix will start a study in patients with diabetic kidney disease, with the trial to be run at the Australian Centre for Accelerating Diabetes Innovations. A Phase II study was conducted in 45 patients in a crossover design, where each patient received treatment with DMX200 before or after placebo for 12 weeks with a six-week washout period. The results show that 25% of patients achieved at least a 30% fall in albuminuria. In those with more severe disease, 56% achieved at least a 25% reduction in albuminuria levels.
Dimerix is capitalised at $53 million with $9.6 million in cash at the end of June.
Bioshares recommendation: Speculative Buy Class A
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