The refund relates to eligible FY16 expenditure across Dimerix’s Receptor-HIT platform technology development program which is evaluating new therapeutic treatments.
Dimerix is a clinical stage biotechnology company committed to discovering and developing new therapeutic treatments identified using its proprietary screening assay.
The company’s lead clinical program, DMX 200, is in Phase II clinical trials for chronic kidney disease and has been granted Orphan Drug Designation status in the U.S. for a medical condition called focal segmental glomerulosclerosis (FSGS).
The condition is a leading cause of kidney failure in adults.
Preliminary data has indicated improved clinical outcomes with chronic kidney disease by significantly reducing proteinuria in animal models.
An estimated US$ 2.6 billion is spent in the U.S. each year, mainly on late stage therapies due to lack of early stage treatment options.
DMX-200: path to registration for FSGS
Phase 2 study
- Part A: Interim - confirmed safety and signs of efficacy: (reporting July 2017); and
- Part B: Efficacy of optimal dose(s) using extended release tablet (commencing 2017).
Complete Extended release tablet formulation
- Pharmacokinetic (PK) study for comparison of current three times daily version with extended release formulation (2H 2017)
Phase 3 development for FSGS – FDA Pre-IND meeting outcomes
- FDA agreed development as an adjunct (not combination) therapy; and
- Primary endpoint discussions positive.
Outlook for next 12 months
- Complete extended release formulation for propagermanium - 1H 2017;
- Report Phase 2 dose escalation (Part A) – July 2017;
- Open IND for PK study – mid 2017;
- PK Study for extended release tablet - 2H 2017; and
- Commence Phase 2 Part B – 2H 2017, using extended release formulation.
- Further pre-clinical studies for nonalcoholic steatohepatitis (NASH) program.
- Potential indications include diabetic retinopathy, cancer fatigue and multiple sclerosis; and
- Research collaborations and assay licensing opportunities.
Find out more from Kathy Harrison at Proactive's CEO Sessions.
Click on city below to register by email
- Intermin Resources (ASX:IRC): MD Jon Price
- Southern Gold (ASX:SAU): MD Simon Mitchell
- Proteomics International Laboratories (ASX:PIQ): MD Richard Lipscombe
- Dimerix (ASX:DXB): CEO Kathy Harrison