INMUNOBIOGRAM® RA

The INMUNOBIOGRAM® (IMBG) is an In Vitro Diagnostic (IVD) immunoassay that combines a biotechnological KIT and a software for data interpretation and report elaboration.

IMBG provides information that would help physicians to personalize the immunosuppressive therapy (IS) in patients with with Rheumatoid Arthritis (RA), and help them to take informed decisions to select the most adequate immunosuppressive drugs (IS) and doses for each patient to reach clinical remission and reduce the side effects of treatment. Currently, this indication is under intensive R+D work in order to make the necessary adaptations from TR to AR.

We expect that IMBG will offer a personalized comparative evaluation of the patient´s sensitivity/resistance profile to a panel of the most commonly used IS in RA clinical practice, potentially allowing physicians to predict and monitor the patient‘s response to a specific IS.

CLINICAL STUDIES WITH THE INMUNOBIOGRAM® IN RHEUMATOID ARTHRITIS

The IMBG is being studied in Rheumatoid Arthritis under a comprehensive clinical plan program, which includes an ongoing proof of concept clinical study in 100 patients iniciated in 2018,  and it is planned to be followed by subsequent validation study

The proof concept Study is being developed in 2018/2019 in Rheumatoid Arthritis and aims to evaluate the feasibility and potential clinical utility of a specifically developed IMBG for Rheumatoid Arthritis. This first-in-clinic study is being done in collaboration with the Rheumatology Unit of “Reina Sofía” Hospital (Córdoba) and “Maimonides Institute of Biomedical Research” (IMBIC).

We expect the proof of concept  2018/2019 in Rheumatoid Arthritis will demonstrate:

  • The IMBG-RA feasibility in patients with Rheumatoid Arthritis at various disease stages and clinical scenarios.

  • The IMBG-RA offers an in vitro potency evaluation of Immunosuppressant drugs (IS) that correlate with sensitivity grades of the patient to a panel of ISs.

  • That a significant proportion of patients with non-controlled RA show low-sensitivity patterns in the IMBG -RA to the medication they are taking.

PRESENTATION PLAN FOR THE ONGOING CLINICAL STUDIES IN RA

Final results of the proof of concept Study 2018/2019 IN RHEUMATOID ARTHRITIS are planned to be presented at the 2019/2020 EULAR Annual European Congress of Rheumatology, and in the ACR/ARHP American College of Rheumatology Annual Meeting.

It is planned to publish a paper with the results of RA proof of concept Study 2018/2019.

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