Objectives:
CKD is caused by progressive and irreversible loss of kidney function. The gradual deterioration of their function leads to the accumulation of life-threatening toxins in the body, which are normally removed by the kidneys. Worldwide, around 3 million patients with end-stage CKD undergo kidney dialysis treatment to substitute for loss of kidney function. Renal dialysis is a life-saving treatment, but it is associated with a huge socio-economic burden. The time spent on treatment affects the quality of life of patients, as well as their functioning in society. Current hemodialysis treatments can only partially remove toxins from the blood, and patients suffer from common symptoms such as anuria, itching, swelling, shortness of breath, sleep disturbances, or muscle and joint pain. Serious complications are also common, including anemia, gout, hyperthyroidism, and various bone disorders. Also, CKD patients receiving dialysis treatment have a 9- to 12-fold increased risk for mortality compared to the general population. These comorbidities not only affect patients’ quality of life, but also represent an economic burden on society as the healthcare associated with these conditions increases the overall monthly cost of care for CKD patients on dialysis. An important medical need in CKD patients that cannot be met by kidney dialysis is impaired water management in the body when the kidneys stop functioning. The lack of urine production causes a sharp deterioration in the quality of life of CKD patients. The relationship between toxins in the blood and these symptoms is clear but poorly addressed in modern kidney dialysis. Accordingly, there is an unmet medical need for therapies that address these particular aspects in hemodialysis patients.
The aim of the PB103 project is to develop an Adjunctive Blood Detoxification device (ABD), used as an add-on to standard hemodialysis therapy that will selectively remove undesired toxic molecules from CKD patients’ blood. A device is to be connected to the hemodialysis device to work in-line during the hemodialysis procedure for a CKD patient, in a hospital or dialysis center setting. Selective capture and removal of these molecules, aimed at achieving the intended therapeutic effects, will be possible thanks to the use of a biologically active element of the medical device – an adsorber containing aptamers immobilized on it. Thanks to the use of the patented PureApta™ technology, licensed to Doto Medical by Pure Biologics, highly specific aptamers will be obtained with its help, and further placed as active molecules onto adsorbers in ABD, allowing the selective removal of toxins that are not effectively removed during conventional hemodialysis, and which play a key role in the pathogenesis of CKD, progressive degradation of kidney function, development of cardiovascular complications or excessive activation of the immune system. The use of a highly selective method will avoid the removal of molecules beneficial to the patient’s body, which is a significant advantage over similar products currently available on the market.
The ABD technology that selectively and efficiently removes unwanted and toxic molecules from the blood of CKD patients, which cannot be removed by standard hemodialysis, will allow doctors to:
PB103 project is comprised of 3 sub-projects, each of which will develop a distinct adsorber aimed at achieving a different therapeutic effect by capturing a distinct set of molecular targets. The work will therefore result in three marketable products, differing in the aptamers and the toxins captured, used by the ABD device, and targeting distinct clinical outcomes for specific clinical manifestations of CKD. The first of the products will be aimed at maintaining residual kidney activity, the second on reducing negative cardiovascular effects of kidney failure and the third at therapeutic effect by inhibiting chronic inflammation.
Project partners and their role in the project:
PB103 project is carried out at medtech company Doto Medical LLC, established as a daughter-company by Pure Biologics, and in partnership with Relitech B.V. – a Dutch engineering company specializing in innovative technological solutions for medical equipment and its automation systems. The role of Relitech B.V. in the project is to engineer the ABD device using their patented technology of targeted kidney dialysis (ABD – Relitech). Pure Biologics has licensed Doto Medical LLC to use its patented PureApta™ platform to develop and use aptamers for CKD and medical device solutions.