Periodic Reporting for period 1 - ATLAS (The first broad-spectrum treatment against pandemic-prone flaviviral infections: Dengue, West-Nile and Zika)
Reporting period: 2023-03-01 to 2023-08-31
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.
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.
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.