FOR IMMEDIATE RELEASE: Seattle | Dec. 17, 2018: IDRI is partner in a European Union-funded consortium that is focused on demonstrating how advanced computer modelling and simulation can be used to reduce the costs of the clinical trials to test the efficacy of new therapies for tuberculosis. In a step towards that goal, the STriTuVaD consortium recently published a technical report entitled “A Computer Modeling System of the Dynamics of the Human Immune System.”

The STriTuVaD consortium, led by Etna Biotech in Italy, includes some of the leading researchers in this field, including IDRI; the University of Cantania and the University of Bologna in Italy; the University of Sheffield in the United Kingdom, Archivel Farma in Spain; Stichting Tuberculosis Vaccine Initiative in the Netherlands and the All India Institute of Medical Sciences in India.

Tuberculosis (TB) is one of the world’s deadliest infectious diseases: one third of the world’s population, mostly in developing countries, is infected with TB. But TB is increasingly becoming problematic for developed countries, due to the increased mobility of the world population and the appearance of several new bacterial strains that are multi-drug resistant (MDR). There is now a growing awareness that TB can only be effectively fought by working globally, starting with countries like India, where the infection is endemic. Once a person presents with the active disease, the most critical issue is the current duration of therapy including high costs  of treatment, the increased chances of non-compliance (which increases the probability of developing an MDR strain), and the time the patient is still infectious.

One promising possibility to shorten the duration of the therapy is new host-reaction therapies (HRT) offered in combination with the antibiotic therapy.

The endpoints in clinical trials for HRTs are time to inactivation and incidence of recurrence. With inactivation, it is possible, in some cases, to have a statistically powered evidence for efficacy in a Phase II clinical trial; however, recurrence almost always requires a Phase III clinical trial with thousands of patients involved and huge associated costs.

The STriTuVaD project will extend the Universal Immune System Simulator, developed by Francesco Pappalardo at the University of Catania, to include all relevant determinants of such a clinical trial. The project will establish predictive accuracy against the individual patients recruited in the trial, use it to generate virtual patients and predict their response to the HRT being tested, and then combine them with the observations made of physical patients using a new in silico-augmented clinical trial approach that uses a Bayesian adaptive design. This approach, when effective, could drastically reduce the cost of innovation in this critical sector of public healthcare and make advanced therapies available at reasonable costs.

About IDRI: As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. Founded in 1993, IDRI has 125 employees headquartered in Seattle with nearly 100 partners/collaborators around the world. For more information, visit www.idri.org.

Contact: Lee Schoentrup | lee.schoentrup@idri.org