Dimerix Limited Announces DMX--200 Tablet Manufacture And Human Pharmacokinetic Study Timeline
MELBOURNE, Australia, 5th September 2017: Dimerix Limited (ASX: DXB), is pleased to announce that manufacturing has been scheduled for later this month to produce the extended release tablet of propagermanium which will be used in the Company’s DMX-200 human pharmacokinetic study and Phase 2b trial in Chronic Kidney Disease.
DMX-200, Dimerix’s lead drug development program which successfully completed a Phase 2a clinical trial in humans, is being developed as an adjunct therapy. The adjunct therapy approach will see a form of a drug which is currently approved and being marketed in Japan, propagermanuim, added as a new tablet alongside the existing standard of care blood pressure medication that patients are taking, called irbesartan.
Dimerix’s Phase 2a human trial, the results of which were reported on 12 July 2017, was conducted using capsules of an immediate release version of propagermanium. When provided to patients in the DMX-200 Phase 2a trial, patients were required to take the drug three times per day. Dimerix has developed an extended release formulation of propagermanium which is expected to be suitable as a twice daily medication for patients, eliminating the need for patients to remember to take the middle of the day tablet each day and providing new intellectual property to Dimerix.
Kathy Harrison, CEO of Dimerix said, “Physicians have indicated that it is important in a commercial tablet for the dosage form to be taken no more than twice per day as, above this, there is often a dramatic drop off in compliance which can be reflected in poor efficacy of the drug. As a result, our new formulation will be seen as more convenient, should translate to better compliance and thus is likely to have a greater chance of success in the long run.”
“Developing propagermanium in this extended release format means we can deliver a more convenient dosing regime to patients. It also enables Dimerix to extend its intellectual property portfolio as the drug we are developing has been formulated to reflect the optimal dosing as informed by the recently completed Phase 2a study. This is a significant value adding step for the DMX-200 program.”
Tablet availability is important to ensure Dimerix can conduct its human pharmacokinetic (PK) study, which is expected to be completed before the end of 2017. The primary purpose of the PK study is to understand the way DMX-200 is processed through the body in the extended release form compared with the immediate release form. It is an important step for confirming the design of Dimerix’s Phase 2b efficacy study, as the data obtained from the PK study will assist in finalising the most appropriate dose selection. Design of the Phase 2b study is well underway and incorporates feedback from leading nephrologists.
- ENDS -
Issued for and on behalf of Dimerix by Instinctif Partners.
For more information please contact:
At the company:
Kathy Harrison
Chief Executive Officer
Dimerix Limited
Tel: +61 419 359 149
E: kathy.harrison@dimerix.com
Media (Australia)
Andrew Geddes
Tel: +61 408 677 734
E: dimerix@instinctif.com
Media (International)
Sue Charles/ Gemma Harris
Tel: +44 (0)20 7866 7860
E: dimerix@instinctif.com
About Dimerix Bioscience Pty Ltd
Dimerix Limited’s (ASX: DXB) wholly owned subsidiary Dimerix Bioscience Pty Ltd is a clinical-stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT). This assay enables the identification of pairs of receptors that function in a joint manner (interact) when ligands, small molecule drugs, peptides or antibodies, bind to them. The Receptor-HIT technology was used to identify DMX-200 in an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. In addition to its own therapeutic programs, the company also earns revenue by providing this technology to global pharmaceutical companies. For more information see www.dimerix.com
About the DMX-200 program
DMX-200 which successfully completed a Phase 2a clinical trial in humans, is being developed as an adjunct therapy, adding propagermanuim to a stable dose of irbesartan. Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients. Propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti-inflammatory properties.
Dimerix released the results of its Phase 2a clinical trial in humans for DMX-200 in July 2017. The trial met its primary endpoint of safety and tolerability in the participating patient group, which included patients with diabetic nephropathy (10), IgA nephropathy (6), and other proteinuric diseases (11). As a secondary endpoint, DMX-200 was shown to reduce levels of proteinuria in a number of patients. This was deemed a “clinically meaningful” result by leading clinicians. Preparations for a Phase 2b trial are underway which will test for efficacy and is expected to start by the end of calendar 2017.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a disorder in which patients show progressive loss of renal function usually accompanied by excess protein in the urine (proteinuria). Levels of proteinuria predict rate of decline of renal function (higher levels = more rapid decline). In part this is believed to reflect direct toxicity, or damage, to the kidneys by proteinuria itself. This establishes a cycle of worsening renal function leading in turn to increasing proteinuria and further kidney damage. Many CKD patients progress to a need for renal replacement therapy or dialysis and / or experience excessive morbidity and mortality from cardiovascular-related diseases.
The prevalence of CKD is rising and as such there is urgent need for treatments that can benefit CKD patients, including reducing proteinuria. In most cases of CKD residual proteinuria continues even with optimal use of existing therapies. Accordingly, therapies designed to further reduce, or abolish, proteinuria, are eagerly sought.
The rationale behind the DMX-200 program is to provide patients with a therapy that can reduce proteinuria in addition to that achieved with standard best therapy. The unmet need of CKD patients is reinforced by Dimerix’s Orphan Drug Designation.
DMX-200, Dimerix’s lead drug development program which successfully completed a Phase 2a clinical trial in humans, is being developed as an adjunct therapy. The adjunct therapy approach will see a form of a drug which is currently approved and being marketed in Japan, propagermanuim, added as a new tablet alongside the existing standard of care blood pressure medication that patients are taking, called irbesartan.
Dimerix’s Phase 2a human trial, the results of which were reported on 12 July 2017, was conducted using capsules of an immediate release version of propagermanium. When provided to patients in the DMX-200 Phase 2a trial, patients were required to take the drug three times per day. Dimerix has developed an extended release formulation of propagermanium which is expected to be suitable as a twice daily medication for patients, eliminating the need for patients to remember to take the middle of the day tablet each day and providing new intellectual property to Dimerix.
Kathy Harrison, CEO of Dimerix said, “Physicians have indicated that it is important in a commercial tablet for the dosage form to be taken no more than twice per day as, above this, there is often a dramatic drop off in compliance which can be reflected in poor efficacy of the drug. As a result, our new formulation will be seen as more convenient, should translate to better compliance and thus is likely to have a greater chance of success in the long run.”
“Developing propagermanium in this extended release format means we can deliver a more convenient dosing regime to patients. It also enables Dimerix to extend its intellectual property portfolio as the drug we are developing has been formulated to reflect the optimal dosing as informed by the recently completed Phase 2a study. This is a significant value adding step for the DMX-200 program.”
Tablet availability is important to ensure Dimerix can conduct its human pharmacokinetic (PK) study, which is expected to be completed before the end of 2017. The primary purpose of the PK study is to understand the way DMX-200 is processed through the body in the extended release form compared with the immediate release form. It is an important step for confirming the design of Dimerix’s Phase 2b efficacy study, as the data obtained from the PK study will assist in finalising the most appropriate dose selection. Design of the Phase 2b study is well underway and incorporates feedback from leading nephrologists.
- ENDS -
Issued for and on behalf of Dimerix by Instinctif Partners.
For more information please contact:
At the company:
Kathy Harrison
Chief Executive Officer
Dimerix Limited
Tel: +61 419 359 149
E: kathy.harrison@dimerix.com
Media (Australia)
Andrew Geddes
Tel: +61 408 677 734
E: dimerix@instinctif.com
Media (International)
Sue Charles/ Gemma Harris
Tel: +44 (0)20 7866 7860
E: dimerix@instinctif.com
About Dimerix Bioscience Pty Ltd
Dimerix Limited’s (ASX: DXB) wholly owned subsidiary Dimerix Bioscience Pty Ltd is a clinical-stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT). This assay enables the identification of pairs of receptors that function in a joint manner (interact) when ligands, small molecule drugs, peptides or antibodies, bind to them. The Receptor-HIT technology was used to identify DMX-200 in an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. In addition to its own therapeutic programs, the company also earns revenue by providing this technology to global pharmaceutical companies. For more information see www.dimerix.com
About the DMX-200 program
DMX-200 which successfully completed a Phase 2a clinical trial in humans, is being developed as an adjunct therapy, adding propagermanuim to a stable dose of irbesartan. Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients. Propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti-inflammatory properties.
Dimerix released the results of its Phase 2a clinical trial in humans for DMX-200 in July 2017. The trial met its primary endpoint of safety and tolerability in the participating patient group, which included patients with diabetic nephropathy (10), IgA nephropathy (6), and other proteinuric diseases (11). As a secondary endpoint, DMX-200 was shown to reduce levels of proteinuria in a number of patients. This was deemed a “clinically meaningful” result by leading clinicians. Preparations for a Phase 2b trial are underway which will test for efficacy and is expected to start by the end of calendar 2017.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a disorder in which patients show progressive loss of renal function usually accompanied by excess protein in the urine (proteinuria). Levels of proteinuria predict rate of decline of renal function (higher levels = more rapid decline). In part this is believed to reflect direct toxicity, or damage, to the kidneys by proteinuria itself. This establishes a cycle of worsening renal function leading in turn to increasing proteinuria and further kidney damage. Many CKD patients progress to a need for renal replacement therapy or dialysis and / or experience excessive morbidity and mortality from cardiovascular-related diseases.
The prevalence of CKD is rising and as such there is urgent need for treatments that can benefit CKD patients, including reducing proteinuria. In most cases of CKD residual proteinuria continues even with optimal use of existing therapies. Accordingly, therapies designed to further reduce, or abolish, proteinuria, are eagerly sought.
The rationale behind the DMX-200 program is to provide patients with a therapy that can reduce proteinuria in addition to that achieved with standard best therapy. The unmet need of CKD patients is reinforced by Dimerix’s Orphan Drug Designation.