European collaboration accelerates new antibiotic development
Antimicrobial resistance is a major global threat to public health, and infections caused by resistant bacteria are on the rise. The consequences of this are loss of life and colossal costs: in the EU alone, costs are estimated at approximately €1.5 billion annually. RISE is leading work in a large European project to scale up candidate drugs and ready them for both animal and human trials.
Despite the considerable need to new develop new antimicrobials, very few have reached the market. Over the last 30 years, only two new classes of antibiotics have been developed.
“One challenge is that it is difficult for many players to invest the large amount of capital that the development of these drugs necessitates. In the EU, we are therefore investing in many projects aimed at expediting their development in a consortium together with the pharmaceutical companies,” says Nicolaas Schipper, researcher at RISE.
New business model affords new opportunities
The EU and the pharmaceutical industry are now investing in a type of partnership between the public and the private sectors – a business model known as a public-private partnership (PPP), which in this case aims to expedite the development of antibiotics.
One of the projects initiated is ENABLE, which since 2014 has operated an antimicrobial medicine platform, where new substances can be developed with the goal of ultimately creating a new candidate drug that can be trialled on humans. Half of the funding is provided by the EU, with the other half coming from pharmaceutical companies involved in the project.
“In the project, RISE is tasked with the pharmaceutical development of the substance, perform toxicity studies, and guidance – that’s our part of the platform. We assist in scaling up the substance to ensure there is a sufficient amount for studying. We are also developing analysis methods, preparations and formulations so that the substance can be given both to animals and humans,” says Schipper.
The consortium comprises 47 partners from universities, the biotech industry and pharmaceutical companies. Uppsala University is leading the project along with a coordinator from the pharmaceutical industry.
“Having RISE as a part of the pharmaceutical development platform in ENABLE has been hugely beneficial, both in terms of providing experience and expertise to our various partners and with regard to the practical development work,” says Anders Karlén from Uppsala University.
Assistance in pharmaceutical development
Not infrequently, new substances are discovered by small companies or universities. Researchers and companies can then turn to ENABLE, and receive assistance from the consortium in further developing these substances through the first stages of pharmaceutical development, which are often challenging.
“It’s an important task, and a big one at that. We have adopted dozens of projects, and a great many have shown promise. A range of requirements must be satisfied to become part of the project,” says Schipper, who considers the project important for many reasons.
“Firstly, we are utilising the expertise existing in academia and the biotech industry to discover new mechanisms and substances, and we have created this platform to facilitate the development of new drugs.”
Candidate was ready for clinical testing in 2019
A candidate drug chosen to undergo clinical trials was presented in November 2018. It has been shown to have an effect on infections caused by some of the more dangerous drug-resistant bacteria. In 2019, the candidate began to be tested in a phase 1 study that continued to show good results.
“The first clinical study always focuses on safety. It’s about finding the optimal dose and identifying any side effects. Studies on the efficacy in patients will follow this,” says Schipper, who explains that RISE works in the ENABLE project in several ways and in different parts of drug development.
“During the spring and summer of 2021, several other antibacterial drug candidates will be safety assessed in non-clinical toxicity studies by us.”