Dimerix’s midwinter Christmas present will be FSGS results in July
Health & Biotech
Health & Biotech
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Special Report: Dimerix expects results for its FSGS clinical trial in July and says so far, it’s meeting the primary endpoint.
Biotech Dimerix has dosed its last patient in a crucial phase 2a clinical trial on focal segmental glomerulosclerosis (FSGS) and is telling investors to expect the hotly awaited results by the end of July.
The company said today there had been no serious adverse effects in the FSGS trial to date, a detail which is the primary outcome Dimerix is looking for in the study.
The trial is one of two due to report in the coming months. The other is into diabetic kidney disease which will see the final patient dosed in July and results to come thereafter.
Both studies are on time and on budget, a rarity in the biotech world.
The phase 2a FSGS study is a double-blind, randomised, placebo-controlled, crossover study designed to evaluate the safety and preliminary signs of efficacy of Dimerix’s drug candidate DMX-200 in patients who are receiving a steady dose of an angiotensin receptor blocker, irbesartan.
Each participant in the study received 16 weeks of DMX-200 and 16 weeks of placebo, separated by a six-week washout period.
The secondary endpoints are for efficacy, such as the per cent change from baseline in 24-hour protein to creatinine ratio after 16 weeks of treatment as compared to a placebo, and the proportion of patients who achieve a pre-defined reduction in proteinuria.
FSGS is a serious and rare inflammatory disease that attacks the kidney’s filtering unit, the glomeruli, causing scarring of the tissues that leads to permanent kidney damage and kidney failure.
It affects children and adults, and there are no treatments on the market today. Because of this, Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe for FSGS.
Orphan designation also provides regulatory and financial benefits, including reduced fees during the product development phase, protocol assistance from the regulatory authorities, and seven-year in the US and 10-year in Europe market exclusivity following approval.
Investors have been highly anticipating the results of this trial, pointing to the fact that some patients have stayed on the drug after they finished the study as a cause for optimism.
Dimerix has organised continued compassionate access to DMX-200 for multiple patients who have completed the study through the Therapeutic Goods Administration’s (TGA) Special Access Scheme.