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PreventSepticShock Report Summary

Project ID: 666328

Periodic Reporting for period 1 - PreventSepticShock (Bioactive AdrenoMedullin is a Novel Outstanding Marker to Predict and Prevent Septic Shock)

Reporting period: 2015-04-01 to 2016-03-31

Summary of the context and overall objectives of the project

Sepsis is a life-threatening condition that arises when the body's response to an infection damages its own tissues and organs. Although sepsis is initiated by infection, it is not the infection per se, which kills the patient, but rather the body’s response to it, in particular, the development of a shock, which is initiated by deterioration of the blood vessel system, hypotension, insufficient perfusion and oxygenation of organs and finally organ failure. For a clinician this situation occurs suddenly and there is no diagnostic tool to predict this event early enough to initiate adequate measures to guide the patient and prevent its death.
Despite of large efforts and developments in the last decade septic shock is still one of the world biggest killer causing 5-6 million deaths a year worldwide. Thus the prediction of septic shock and stratification of high risk patients is still an unmet medical need.
Bio-ADM is a novel marker in sepsis to reliably identify patients with a high risk of developing septic shock, who are having a high mortality and a need for vasopressor treatment.
During the project scientist of Sphingotec (SPH) are developing bio-ADM as a powerful marker to predict the fatal shock progression in severe sepsis.
Accordingly, the main goal of the project is to validate the clinical utility of bio-ADM as a biomarker in European intensive and emergency care for identification of critically ill patients with the highest risk of developing shock, in order to enable earlier treatment options. This will imply a change in standard of care in sepsis patient management. Furthermore, all necessary dissemination will be made to guarantee quick market up-take and broad clinical application of the marker.
Within first period of the project, Sphingotec worked on the following objectives:
1. Prototyping for clinical application
Establishing a highly reliable in-vitro diagnostic (IVD) bio-ADM assay for routine clinical application. For this purpose, on the basis of the already developed robust RUO bio-ADM test, a CE labelled IVD assay had to be established during the first period of the project.
2. Clinical Validation
Currently a large observational clinical study with 600 sepsis patients on the Intensive Care Units (ICU) had to be conducted aiming the following targets: (i) Confirmation of very significant data received in the pilot study of Marino et al 2014 Crit Care, (ii) Validation of the designated cut-off-value for bio-ADM measurement in clinical routine to identify patients with highest risk to die and to indicate vasopressor therapy at the earliest stage and thus help to save lives, (iii) Show the performance of the marker in comparison to established clinical chemistry parameters (according to international sepsis guidelines), (iv) Deliver clinical data for a broad clinical exploitation of the biomarker.
3. Establishing automation of the assay to enhance the European and world wide exploitation
The bio-ADM analysis had to be adapted for automation - random access format of the assay and a point of care platform (POC) together with designated industrial licensing parties.
4. Scale-up of production capacity and preparation of the company for growth
New staff for the project (for research, development, clinical profiling, production and marketing) had to be employed and development of structures for continuous growth after the project needed to be implemented..
5. Market replication
For dissemination of bio-ADM as a clinical marker, several retrospective studies for the application of bio-ADM in analogous clinical questions had to be conducted, e. g. bio-ADM in German and international cohorts for sepsis, and shock, in acute heart failure and acute myocardial infarction.
6. Prepare product launch
Launch of bio-ADM as a clinical marker in 2017 had to be prepared.
7. Fulfilling regulatory requirements
During the project all work for the bio-ADM assay had to be conducted in compliance with the European Directive on In Vitro Diagnostic Medical Devices (98/79/EC), as well all regulatory ethic and data safety requirements had to be fulfilled.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first project period work has been conducted in all work packages. In the following a brief overview is given:
In WP 1 - Routine assay in IVD format (i) small batches of assay components have been produced and validated, (ii) material for all serial tests to be used in the project has been produced, (iii) all technical assay data have been acquired to ensure IVD conform test performance, (iv) technical documentation including the preparation and quality protocols for all components for CE declaration of conformity IVD registration via DIMDI are accomplished.
In WP 2 - Sepsis cohort study 21 study sites have been initiated and till midterm 85% patients have been included, and assessed according to international standards.
In WP 3 - Forwarding to automation bio-ADM assay components have been produced and transferred to potential licensing partner for assay feasibility studies.
In WP 4 - Dissemination and exploitation action (i) presentation materials have been prepared, (ii) a marketing website explaining the PreventSepticShock concept has been published, (iii) 12 of oral presentations have been given on national and international conferences, (iv) Sphingotec attended the relevant commercial exhibitions, (v) introduced information for bio-ADM to 7 potential licensing parties, and (vi) furthermore, small studies are planned and will be executed during the project. (vii) Marketing and dissemination strategy for commercialisation has started and is supported by external consultants.
In WP 5 - Project management several meetings have been held, as well as regular biweekly telephone conferences with clinical contract research partner EDDH. Critical documents are transferred from Sphingotec to study partner and vice versa. EDDH gave monthly short reports on the progress of the recruitment.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In WP 1 - Routine assay in IVD format a chemiluminescence assay in 96 well format, including standard and control samples has been designed and is ready to be used in clinical environment. The technical performance is excellent.
In WP 2 - Sepsis cohort study, first, the multi-centre observational study has been set-up. Importantly all regulatory and ethical aspects, study documents design, and quality control management have been established. Secondly, about 507 of the projected 600 sepsis patients are included.
In WP 3 - Forwarding to automation, transfer to the automated technology has been started with first positive results.
In WP 4 - Dissemination and exploitation action dissemination materials have been designed to be used in 12 conference presentations and in 4 exhibitions.
In WP 5 - Project management 3 Meetings were held, technical and administrative management has been preceded continuously.
Importantly, all ethical requirements have been fulfilled in all participating centres as well gender bias is avoided within the scientific community through the distribution of relevant publications (Helsinki report).

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