News and Announcements
Dimerix (ASX: DXB) set to launch DMX-200 clinical trials for patients with Chronic Kidney Disease
- Published June 14, 2018 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
KEY TAKEAWAYS:
- Dimerix will launch the next stages in its DMX-200 trials into Chronic Kidney Disease.
- There will be two concurrent clinical trials focusing on two forms of CKD; Focal Segmental Glomerulosclerosis and Diabetic Kidney Disease.
- The DKD trials will commence their Phase 2b trials in about 40 patients following a successful Phase 2a.
- FSGS will commence Phase 2a study in around ten patients.
- Preliminary results are expected in 2019.
Dimerix, a biotechnology company, is launching DMX-200 clinical trials, following successful completion of their Phase 2a Study into patients with Chronic Kidney Disease (CKD). Patients with CKD show progressive loss of renal function and excess protein in Urine. The next Phase will undertake two separate trials each focusing on one of two forms of CKD; Focal Segmental Glomerulosclerosis (FSGS) and Diabetic Kidney Disease (DKD).
Following effective response of the Phase 2a study for patients with DKD, 45% of patients chose to continue DMX-200 under the Special Access Scheme’ arrangement after completion of their trial dosing. The results for DKD was compelling enough to support this follow up Phase 2b trial in a larger patient group while beginning their Phase 2a study into patients with FSGS, in which Dimerix has Orphan Drug Designation in the USA.
The trial is designed to provide every patient with the best standard of care medication for at least months before and throughout the trail, and then they will receive DMX-200 (which combines the two drugs irbesartan and propagermanium) or placebo at different period of the study. The trial includes ten patients with FSGS and 40 with DKD running concurrently.
They will utilise the same Investigators and vendors saying in time and cost.
IQVIA, a leading global contract research organisation, will be a facilitator and offer support as a critical vendor for the trials. Each trail will be at more than ten clinical trial sites in Australia. The ethics application are intended to take place in June, with patient recruitment being in Q3 2018. The preliminary data from the DKD study is expected in Q3 2019 and FSGS in Q4 2019.
About Dimerix Ltd (ASX: DXB)
Dimerix Limited (ASX: DXB) is a clinical-stage drug development company with our lead program DMX-200, currently in Phase II clinical trials for Chronic Kidney Disease (CKD).
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