Doctor Jozsef Balla, head of the Department of Nephrology and Hemodialysis Unit at the University of Debrecen in Hungary is, since the spring of 2016, a member of A1M Pharma's Scientific Advisory Board. We interviewed him about his research and the potential of A1M within acute kidney injury (AKI).

How is your work divided between your different assignments?
I have clinical background and I spend around half of my time in clinic and half of my time on scientific research. Apart from chronic kidney disease, we work with intensive care patients with organ failure, including cases with acute kidney injury. We receive 3-5 patients every day requiring dialysis, which means purifying the blood externally. In addition to this, I am also a member of the Advisory Board of the Ministry of health in Hungary and we have, among other things, been a part in designing new guidelines for dialysis. The Ministry of Health is very helpful when it comes to reimbursements for treatment of intensive care patients.

How did you first come into contact with A1M Pharma and their research on A1M?
I have worked with hemoglobin and heme related research since the 90's, and I was in contact with Magnus Gram a few years ago concerning A1M, but that was not our focus at the time. Later on, I was invited to give a presentation for a number of prominent international researchers in Lund, and I spoke to Bo Åkerström and Magnus Gram about A1M's role in the breakdown of red blood cells and the release of harmful heme, which causes organ damage through oxidative stress. We also received samples of A1M that we used in our research which was co-published in the journal Free Radical Biology last year.

How extensive is the need of an AKI treatment within the emergency care?
It is a very big problem within several areas that require emergency surgery, for example in connection with cardiac arrest. As many as two thirds of our patients within emergency care suffer from kidney injuries, and one in ten suffers from kidney failure requiring dialysis. In these patients we see signs of reduced levels of the plasma protein haptoglobin, which indicates that a breakdown of hemoglobin and a release of harmful heme have occurred. For these patients, A1M could be one of the tools needed to prevent damaging effects on the kidneys. So these are extensive problems involving huge healthcare costs.

How interested would you say that the global pharmaceutical companies are in AKI treatments?
Since as many as 70 percent of emergency care patients suffer from some type of acute kidney injury it is an immense problem, which is well acknowledged within the industry. A candidate drug that offers protection against heme related oxidative stress would reduce mortality and reduce the need for dialysis, and it would also be of interest as protection against other types of organ damage. A lot of money is being invested to develop new treatment strategies within AKI, and we have seen several new projects emerge and fail. So it is definitely a “hot” scientific area.

Which sub indication within AKI do you think is the most suitable for A1M Pharma initially?
It is important to choose an indication with extensive heme related oxidative stress. It is also important to be able to administer the pharmaceutical at the right time enabling it to prevent damage. For patients suffering from AKI induced by bacterial infections it is perhaps less suitable if the organ damage has already occurred when they are under treatment. That is why I think that applications in connection with emergency surgery with a high risk of organ damage would be a good area to focus on.

What would you say are the major challenges that the company will face within AKI going forward?
There are obviously a number of challenges, one being that patients may suffer from disorders of various origins which makes the treatment and its results more complex. I believe, however, that the timing of the treatment will be crucial in order for the pharmaceutical to be administered when heme related oxidative stress occurs. One way to optimize the timing of administration might be to develop a bio marker such as oxidization of hemoglobin, a technology that already exists. Therefore, I think it will be essential to conduct extensive in vivo studies in humans in order to optimize the timing of administration.

How unique would you say that A1M Pharma's approach for treatment of AKI is compared to other treatments under development?
Commercially, there is no treatment of heme related oxidative stress available today, but apart from A1M there are also the plasma proteins hemopexin and haptoglobin, which are promising candidates as well. The difference however, is that these plasma molecules are too big to penetrate the tissues in the way that A1M does. In addition, the plasma proteins have a longer onset of action than A1M, in which the mechanism of action is immediate as we have seen in our tests with cardiac patients. These differences also suggest that it might be a good idea to combine these two types of candidates.

Addition: Earlier this year, A1M Pharma initiated a research collaboration with global biotherapeutics company CSL Behring concerning combined treatments with A1M and plasma proteins such as hemopexin and haptoglobin.
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