Cybernetic Dialysis | CYBERNETIC DIALYSIS

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Subject matter

Pharmaceutical and drug development research organizations produce many effective treatments that address debilitating diseases and save and improve millions of lives

Safety and effectiveness of a drug is achieved often based on a precise and calibrated dose and exposure to the drug (too little results in lack of efficacy, too much is often associated with side effects)

Drug development research aim to optimize the dose based on average patients and take into account some of patient characteristics that may affect exposure, such as body weight, age, sex or type of disease

Whilst dose for typical patients is well studied in the clinical development programs, there is often little to no inclusion or study is performed on subgroup of patients who are candidates for drug treatment but also have end stage kidney disease and are receiving dialysis

Another subgroup of patients are those with acute kidney injury that are mostly in intensive care units (ICUs) such as sepsis, severe dehydration, blood or fluid loss and low blood pressure that may undergo dialysis for a period

Drug development programs rarely include receiving the investigational drug in patients that also receive dialysis concomitantly

Dialysis often remove medications from blood and sometimes it removes the medication completely. This would result in lower than required exposure and in some cases eliminates the efficacy of the medication despite “normal dose” administered to patient. This is because the “normal dose” has been optimized for patients that are not receiving dialysis concomitantly

There is often no guidance or research, during development program of a new investigational product, and even years after the approval of drug for use in patients, on how to use or what dose to use in patients receiving concomitant dialysis

CYBERNETIC DIALYSIS

Relevance

How does CYBERNETIC DIALYSIS help?

CYBERNETIC DIALYSIS provides a system to predict and generate supportive data to assess the potential effect of dialysis on medications concomitantly administered to patients.

There are many types of dialyses, dialysis equipment and set up (different hemofilters, different dialysis solutions, flow rates and techniques) that are difficult to study all in a range of patients. CYBERNETIC DIALYSIS can provide or interpolate across a range of dialysis systems in patients and provide an accurate estimate of effect of dialysis on medications received by patients.

CYBERNETIC DIALYSIS provides a sound basis for dose guidance in patients receiving any medication concomitantly with dialysis.

Recall that currently prescribing information (PI) for vast majority of drugs on the market, in development or any published study, provide little to no guidance for dosing in patients receiving dialysis. CYBERNETIC DIALYSIS is a great leap to fill this gap and provide sound basis for selecting and administering the right dose of drug in patients receiving dialysis

Use and impact

Need

Use and impact of this technology

CYBERNETIC DIALYSIS provides a reliable, validated and tested system to guide accurate selection of dosing in patients receiving dialysis for drugs in development or drugs that have been marketed but there are no adequate studies available for experience for use in patients receiving dialysis

Patients receiving dialysis, by definition, are vulnerable and often experience life threatening conditions. Dose selection in this group of patients due to lack of guidance or information will greatly benefit from having a reliable and proven method to determine individualized safe and efficacious dose in patients receiving dialysis

In the U.S., according to a NIH report, as of early 2025 there are more than 852,000 patients with chronic kidney disease that receive dialysis. In addition, in a separate report, NIH reported more than 10,000 patients in 2022 received dialysis due to acute kidney injury. These numbers are on the rise due to increase in underlying conditions such as diabetes and hypertension

How it works

Technology

How does CYBERNETIC DIALYSIS work?

CYBERNETIC DIALYSIS has three main components:

Laboratory experiment that performs testing with blood or plasma containing drug at relevant therapeutic concentrations, in a range of conditions such as filters, dialysates, buffers and durations

Build a model for pharmacokinetics of drug administered in human with normal renal function and no dialysis

Incorporate and add a dialysis compartment into the human pharmacokinetic model to simulate a range dialysis systems with dialysis parameters set to realistic conditions that are commonly used in patients undergoing dialysis in clinical practice

Who should use this technology?

Application

Pharmaceutical companies developing new drugs can utilize this method to identify and assess the effect of dialysis on their investigational drug early in the development process (along with Phase 1 studies) to gather adequate information and confidence to allow dialysis patients in Phase 2 or Phase 3 studies, or at least provide some guidance for dosing in the drug prescribing information based on CYBERNETIC DIALYSIS results. At present, most Phase 2 and Phase 3 studies routinely exclude patients receiving dialysis and there is little to no guidance for dosing dialysis patients at the time of drug registration for marketing because, at least in part, there is no information on the effect of dialysis on the investigational drug

Next step

Interested in CYBERNETIC DIALYSIS?

Contact us to discuss your programme and how CYBERNETIC DIALYSIS can support dose guidance for patients receiving dialysis.

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