Archivel Farma is one of the eight partners of STriTuVad consortium, whose overall goal is to demonstrate how advanced computer modelling and simulation can be used to reduce the costs of the clinical trials required to test the efficacy of new therapies for tuberculosis.
Tuberculosis (TB) is one of the world’s deadliest infectious diseases, with one third of the world’s population infected. Patients are mainly concentrated in developing countries, but TB is a growing problem in developed countries due to the appearance of several new bacterial strains that are multi-drug resistant (MDR).
Once a person presents with the active disease, the most critical issue is the current duration of therapy. One promising possibility to shorten the treatment time is new host-reaction therapies (HRT) offered in combination with the antibiotic therapy.
The endpoints in the 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 Prof 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 HRTs being tested, and then combine them with the observations made on physical patients using a new in silico-augmented clinical trial approach that uses a Bayesian adaptive design.
This approach, where found effective, could drastically reduce the cost of innovation in this critical sector of public healthcare and make advanced therapies available at reasonable costs.
The partners of the STriTuVad consortium are Etna Biotech (Italy), Università degli Studi di Catania (Italy), University of Sheffield (United Kingdom), Archivel Farma, Stichting Tuberculosis Vaccine Initiative (The Netherlans), Infectious Disease Research Institute (United States), All-India Institute of Medical Sciences (India) y Alma Mater Studiorum – Università di Bologna (Italy).