We want to develop better and faster-acting medicines to fight tuberculosis and therefore bridge the gap between the scientific discovery and the market in order to provide affordable TB treatment to anyone in the world.
The process of bringing a new drug to the market once a new molecule has been identified includes several key mandatory steps that can take up to 8 years.
The full process includes the following phases:
Pre-clinical phases (trials on micro-organisms/animals).
It includes many steps such as the ADME profile, Good Manufacturing Practice (GMP), Active Pharmaceutical Ingredient (API), Toxicology studies, Production of clinical supplies (transformation into tablets) and preparation of regulatory documents for review and approval.
The pre-clinical phase is crucial to allow human trials, however this is the most difficult part to be funded. Neither pharmaceutical companies, nor governments want to invest in a drug that has yet to prove itself, which is why this phase is often called THE DEATH VALLEY.
Clinical phases (human trials) involves the following steps:
- Phase I trials, in healthy volunteers, in order to determine safety, tolerability and pharmacokinetics.
- Phase II trials, initial reading of efficacy and further exploration of safety
in small numbers of sick patients.
- Phase III trials, to determine safety and efficacy in sufficient large numbers of patients.
PBTZ 169 was discovered and developed by the European Commission’s 6th Framework (FP6) consortium NM4TB – New Medicines for Tuberculosis (2006 – 2011) and 7th framework (FP7) consortium MM4TB – More Medicines for Tuberculosis (2011 – 2016). The Fondation iM4TB has been created to meet the financial needs of the pre-clinical and clinical phases, giving the opportunity to our scientists to further develop this very promising drug candidate as well as others in the future.
A large part of the pre-clinical and clinical development underpinning PBTZ169 is provided by the Ecole Polytechnique Fédérale de Lausanne (EPFL) and the Bill & Melinda Gates Foundation. While these institutions have provided much of the funding needed, it doesn’t cover all the costs necessary to bring PBTZ169 to the point where a pharmaceutical company can manufacture it in large quantities.