“With this product the Beneficiary will revolutionize kidney transplantation market and will become a key player in this system.”
(2018 European Commission Report)
BH-PILOT STUDY 2015 RESULTS
BH-Pilot 2015 was a clinical study performed during 2015-2016 in “La Paz” and “Puerta de Hierro” University Hospitals (Madrid). The study included 70 patients at least 1 year after the renal transplant (immunosuppression maintenance period). They were classified into three categories depending on their immunological risk evaluation:
- High-risk patients (history of rejection, positive HLA antibodies, impaired renal function, or any combination of the previous criteria)
- Controlled patients (with conventional maintenance immunosuppression)
- Low-risk patients (lack of risk criteria and treated with low levels of IS for years).
Data of patients’ clinical and immunological history were collected; an extensive battery of biomarkers (proteomics, metabolomics and cell phenotyping) was performed to complement the risk information, and 10 ml of blood was taken to be tested with the IMBG
The study outcomes indicated a positive proof of concept for IMBG that can be summarized in the following points:
The outcomes of the study indicate that the IMBG enables the measurement of the sensitivity/resistance profile of patient´s immune system cells to immunosuppressant medication, and can detect patients with bad clinical prognosis due to IS low sensitivity.
WHEN AND TO WHOM SHOULD THE IMBG BE PERFORMED
The test has been clinically tested in patients after more than one year of the transplant. The reason is that currently the major challenge for clinicians is to improve the graft survival after one year, reducing the risk of chronic allograft injury due to rejection, and avoiding at the same time immunosuppressive adverse effects like infections and malignancies. It is planned for the IMBG to be tested as well for its use in patients before transplantation.
It can be used to identify and monitor patients at risk of rejection (who might require an increase of immunosuppression or a change in the immunosuppressive regime prescribed), and in patients with low risk to profit from a gradual reduction of immunosuppression and avoidance of severe side effects.
Estimated monitoring frequency will depend on the patient profile:
- An IMBG should be done to all patients at baseline, once the immunological system has got stabilized after the induction therapy (6 months post RT).
- In the maintenance phase it is estimated that 1 IMBG per year should be performed in high immunological risk patients.
- Patients who present immunological events (ie. dnDSA) or adverse events which can lead to a change in immunosuppressive regimen can require an additional IMBG before undertaking a treatment change. The development of de novo (dn) DSA beyond one-year post-transplantation has been demonstrated to be strongly associated with graft loss through antibody-mediated rejections, and is often related with underimmunosuppression.
A pharmacoeconomic model has been developed to estimate the potential impact of the IMBG in clinical outcomes and cost savings in the follow-up period of patients with RT. Cost savings are expected to happen:
- In patients with high immunological risk that show low-sensitivity patterns to the IS they are taking. They can benefit from a change in IS regimen to decrease the graft rejection risk.
- In patients with good clinical evolution and a high sensitivity pattern to their IS regimen. They can benefit from dose adjustments/reductions to decrease the risk of IS adverse reactions like metabolic disorders, opportunistic infections or malignancies.
Direct costs associated with graft failure (dialysis, retransplantation), IS therapy, and Adverse Events management were obtained from Spanish sources.
Key results of the analysis were:
- The use of the the IMBG would entail a potential risk reduction of graft failure with a saving of costs per HR patient in 5 years of € 20,279 (95% CI € 17,512-23,105) and a 100% saving probability
- The use of the IMBG would entail a potential reduction in the AE rate that would generate savings per non-HR patient in 5 years of € 3,328 (95% CI € 451-7,957) and a 99.5% saving probability
This pharmacoeconomic model has been sent to be presented in the next congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR 2019).
This model can be easily adapted for different countries and health care systems as long as data of transplantation maintenance costs are available.
Biohope expects to achieve CE Mark on 3Q 2019, as the company will accomplish all the needed legal requirements:
- The TRANSBIO study results (International Study)
- Technical file of our kit by QA standards
- ISO13485 certification.
Biohope expects to submit to FDA’s consideration for the IMBG-TR in 2020.