Earlier this month the biotech company Dimerix Pty Ltd, based in Melbourne, reported extremely encouraging results from its recent clinical trial for chronic kidney disease, with their anti-inflammation drug DMX-200.
Recently, I was delighted to meet with the CEO of Demerix, Ms Kathy Harrison and to talk about the results and the opportunities for kidney patients.
What DMX-200 does
One of the first signs of kidney disease is albumen in our urine. Albumin is a type of protein that is normally found in the blood. We all need protein; it’s an important nutrient that helps build muscle, repair tissue, and fight infection. But protein should be in our blood, not our urine.
If our kidneys are damaged (by high blood pressure, diabetes, etc), protein can “leak” out of the kidneys into our urine. Having protein in urine is called “albuminuria” or “proteinuria.” If that is not bad enough, our immune system often then reacts by inappropriately attacking our own kidney cells causing inflammation and even more proteinuria, in a rapid downhill spiral.
Dimerix’s DMX-200 is designed to help slow or even stop proteinuria, by reducing the inflammation.
New drugs usually go through three phases before release
- Phase I clinical trials test a small group of people (e.g. 20-80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).
- Phase II clinical trials may test from twenty to several hundred to check that it works as intended and to further evaluate its safety
- Phase III studies may test several hundred to several thousand by comparing the therapy to other therapies, monitoring for adverse effects, determining dosing schedules etc.
These results were from the first part of a Phase II trial (Phase IIa), conducted in Melbourne. Of the 24 patients who completed the trial, six achieved more than a 50% drop in proteinurea levels (25%). Fifty percent is a major reduction and a clinically meaningful result, halting what can be a rapid decline to complete kidney failure.
Conversely, four weeks after treatment stopped, three patients experienced more than a 50% increase in proteinurea levels, returning to previous, pre-trial levels. This suggests that the Dimerix treatment not only slowed the proteinurea but helped maintain it at that lower level.
Importantly, the trial also demonstrated that the treatment appears to be very safe: there were no serious adverse events.
Aside from the promising results, Ms Harrison said further analysis also identified which patient sub-groups are more responsive to this treatment, but at this stage that data is being kept confidential for competitive reasons.
Special early access
Of the 24 patients, 11 (45%) have continued on treatment under the Special Access Scheme. This is an arrangement where the TGA (Australia’s FDA) allows Dimerix to offer patients the opportunity to stay on the treatment after finishing the trial (at little or no cost!), even though it has not been formally approved.
The Next Trial – Getting involved
The next trial, the Phase IIb study, is expected to start towards the end of 2017. It will look at a more specific dose and treatment for a longer period at that optimum dose. It’s expected that about 30 patients will be treated for 6 months.
This new study will recruit a more targeted patient population based on responders in the Phase IIa trial, in addition to patients with the rare FSGS (focal segmental glomerulosclerosis) disease, which is one of the causes of chronic kidney disease.
The new study will be conducted around Australia, in Melbourne, Sydney, probably Brisbane and Perth.
If you wish to be involved, you can register your interest now via email@example.com, or shortly, via a Registration button on the website. Dimerix will acknowledge your interest and add your name to their register of interested patients. In the last quarter of 2017, they will advise you of the process for getting involved (via your nephrologist).
DMX-200 is an exciting new development for patients with chronic kidney failure everywhere. Unlike stem cell treatments, promising, but on the distant horizon, this has the potential, to slow and even stop proteinurea in its tracks for some patients, now. It’s so close we can almost touch it – in fact, you can if you are part of the trial.
General release could be a year or more away, but from these results, DMX-200 is shaping up to be our next weapon of choice in humanity’s ongoing war against kidney disease.
Note: For the speculators amongst us, Dimerix shares are available on the Australian Stock Exchange as DXB, at $0.012 per share.
For the technically minded
Dimerix’s treatment involves the combination of two existing drugs, irbesartan with propagermanium. Using its core technology, called Receptor-HIT, Dimerix hypothesised that two receptors that are commonly found in the kidney, angiotensin II type I and CCR2, have a joint interaction. In preclinical studies, it then showed that by blocking both receptors, more than an additive effect could be achieved in kidney disease. Irbesartan, an anti-hypertensive drug that is prescribed to 70% of people with CKD, blocks the angiotensin receptor and propagermanium, which is an anti-inflammatory compound, blocks the CCR2 receptor.
All patients in the study were dose escalated across five different doses from 30 mg per day to 240 mg per day of propagermanium (no placebos). All patients entering the study were already receiving irbesartan. One aspect the company is building data on is the optimum dose with animal studies and results from competitors showing that too high a dose can reduce treatment benefit.