Dimerix announces 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 programme, 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 the 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 3 times/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 it is important in a commercial tablet for the dosage form to be taken no more than twice a day, 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 programme.”
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.