NAVIPP

Juin 25, 2024

Overview

Taking the recent COVID-19 pandemic as an example, access to broadly applicable therapeutic antivirals would have had a major impact, decreasing the human toll of the disease, and alleviating the burden carried by health care systems. It is urgent to focus resources and efforts on the development of broad spectrum antiviral drugs against unknown pathogens.

The New Antivirals for Infections with Pandemic Potential (NAVIPP) consortium aims to strenghten the EU’s readiness and response capacity to viral threats by assembling an international R&D platform for antiviral drug development against pandemic prone pathogens.

Associating 12 partners from 9 different countries, NAVIPP is a 5 years Horizon Europe funded project with a large budget of 6 million euros.

A dedicated website is running. Visit it for more information.

Consortium

PARTNERS

Project Coordination

ERINHA is the Coordinator of the NAVIPP project.

Activities

The ISIDORe project is organized into 7 Workpackages – working groups dedicated to a specific set of activities.

WP1 (GSK) – Generation of chemical diversity and phenotypic high throughput screening

To establish a tailored library of 125k compounds from GSK internal database and other outsourced databases (to be tested for Filovirus, Henipavirus and Flavivirus infection)
To perform phenotypic high throughput screening on these libraries and generate dose-response data for hits
To explore structure-activity relationship of validated primary hits

WP2 (CSIC) – Primary hit validation and definition of the antiviral spectrum of antiviral candidates

To assess the spectrum of activity of the primary hits using the full panel of NAVIPP priority viruses (Broad spectrum vs. Family-selective vs. Virus-specific, etc.) in conventional 2D models
To assess the spectrum of activity of the primary hits using the full panel of NAVIPP priority viruses (Broad spectrum vs. Family-selective vs. Virus-specific, etc.) in ex vivo models
To start exploring the step of the viral cycle impacted by the hits

WP3 (ERINHA) – Preclinical evaluation

To evaluate drug metabolism and pharmacokinetics (DMPK) properties
To evaluate safety and tolerability in silico and in vitro
To perform Physiologically based Pharmacokinetic / Pharmacokinetic Pharmacodynamic Modeling (PBPK /PKPD)
Structure Activity Relationship (SAR) definition for selected series to generate tool compounds for in vivo pre-clinical proof of concept (PoC)
In vivo evaluation of the antiviral effect in different infection models.

WP4 (MPI) – Mode of Action (MoA) and target identification

To define the molecular target of a selected group of antiviral candidates identified by phenotypic screening (WP1) and sent to WP2 for validation.
Generate target engagement data to support mechanistic modeling and simulation (M&S) to inform Phase 2a clinical trial design.

WP5 (AFFILOGIC) – Enabling antivirals’ implementation

Explore innovative delivery systems for the administration of broad-spectrum antivirals (BSAV)
Develop a draft generic target product profile (TPP) for Nipah virus antivirals for submission to World Health Organization (WHO) for endorsement
Develop a draft TPP for dengue virus antivirals for submission to WHO for endorsement.

WP6 (UOXF) – ADAptive Platform Trial for antiviral screening in patients with early symptomatic dengue (ADAPT)

To develop methodology for PK/PD assessment of candidate antiviral drugs in early dengue.
To conduct a Phase 2a randomised, adaptive, open label trial in patients with early symptomatic dengue infection in Vietnam
To provide proof of concept for the rapid assessment of in-patient antiviral activity for repurposed and novel therapeutics for dengue using the rate of viral clearance as the primary virological endpoint.

WP7 (ERINHA) – Coordination, project management, communication & dissemination

This WP, led by the coordinator ERINHA through the project management team (PMT), will ensure effective and efficient coordination and management of the project, as well as proper internal and external communication and dissemination, and exploitation.

Projects