The first broad-spectrum treatment against pandemic-prone flaviviral infections: Dengue, West-Nile and Zika

Informazioni relative al progetto

ATLAS

ID dell’accordo di sovvenzione: 190197515

DOI

10.3030/190197515

Progetto concluso il 10 Ottobre 2024

Data della firma CE 21 Aprile 2023

Data di avvio 1 Marzo 2023

Data di completamento 31 Agosto 2026

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 14 465 988,75

Contributo UE

€ 2 499 999,00

Coordinato da

PROTINHI BV
Netherlands

Periodic Reporting for period 1 - ATLAS (The first broad-spectrum treatment against pandemic-prone flaviviral infections: Dengue, West-Nile and Zika)

Periodo di rendicontazione: 2023-03-01 al 2023-08-31

Sintesi del contesto e degli obiettivi generali del progetto

WHO, governments and health institutes are urgently seeking methods to prevent future catastrophic flavivirus outbreaks affecting millions (annually >40% global population at risk, resulting in ~395M infections, >25,000 deaths of which mainly children, 750.000 disability-adjusted life years and >€9B direct & indirect costs). As there are no effective treatments or vaccines available, ATLAS will provide a breakthrough in broad-spectrum antivirals: the first-in-class drug to combat the global health emergency of flaviviral infections. In the ATLAS project, Protinhi will finalize clinical trial-enabling studies and pharmaceutical development and obtain proof-of-concept in humans by conducting Phase 1 and Phase 2a clinical trials against the most common flavivirus: dengue. This will put the company in an excellent position to attract interest from pharmaceutical companies (e.g. Gilead, J&J, MSD) for a strategic partnership for late clinical development and commercialization.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During P1 we have focused on the first WPs essential to prepare for and enter clinical trials. Protinhi has performed extensive studies on CMC, drug substance and drug product. These are all essential steps to have achieved in order to become ready for initiating clinical studies and have all information present that is needed for scientific advice from tegulatory bodies (e.g. EMA). Most of this is development work and we made achievement in obtaining a drug substance and drug product that are fulfilling the criteria to enter the GLP tox studies.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

In the processes decribed above, we have implemented technology to our unique compound to ensure that we in prinicple can engage in a one dosing regime study (e.g. compared to the 30 pills regime of the current Covid antiviral pills). this is a result beyond the state of the art and will be an unique selling point for the protinhi approach. We will further substantiate these finding in follow up studies towards the clinic and implement this also in the clinical trial designs. Potentially these will also lead to additional IPR protecting Protinhi's technology.