Our mission is to develop better and faster-acting medicines to fight tuberculosis and bridge the gap between 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 takes up to, on average, 8 years.
The full process from discovery to market includes the following phases:
Pre-clinical phase (trials on micro-organisms/animals):
The pre-clinical phase includes many steps such as the ADME profile, Active Pharmaceutical Ingredient (API), Toxicology studies, production of clinical supplies of the drug, and preparation of regulatory documents for review and approval.
This 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. It is this Death Valley that was the motivating idea of creating Innovative Medicines for Tuberculosis Foundation.
Clinical phases (human trials) involve the following:
- Phase I: trials in healthy volunteers in order to determine safety, tolerability and pharmacokinetics (the fate of substances administered to a living organism). PBTZ169 has successfully passed a phase Ia trial, held between December 2017 and March 2018. In this single ascending doses phase Ia trial, the safety, the tolerability as well as pharmacokinetic/pharmacodynamic (PK/PD) parameters were evaluated. Our molecule is currently being investigated in a phase Ib study, in which the safety, tolerability and PK/PD parameters of multiple ascending doses are evaluated. The phase Ib will be completed by autumn 2019.
- Phase II: trials to determine initial reading of efficacy and further exploration of safety in small numbers of sick patients.
- Phase III: trials to determine safety and efficacy in a 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. PBTZ169 has happily manage to pass the Death Valley and start the clinical phase of bringing this new medicine to those suffering from tuberculosis.
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.