Europe needs a strategy

In the successful fight against COVID-19, besides prevention, diagnostics and vaccines, potent and secure therapeutics are essential. However, therapeutics are hardly available, as Dr Christoph Spinner, Pandemic Officer at the Technical University Munich Hospital criticises: “Even more than a year into the pandemic, we still have nearly no effective therapeutics for the treatment of COVID-19 patients. Despite the possibilities of vaccination, we continue to depend on research into effective substances against SARS-CoV-2 – also and especially with regard to the increased incidence of viral mutations”. For the rapid development of urgently needed vaccines, politics has provided a lot of money, both in Germany and in Europe. And, just recently, the EU Commission proposed a new European biodefense plan against COVID-19 variants called “HERA Incubator” to speed up development, approval and manufacturing of new vaccines adapted to mutations.

Bavaria as a pioneer

So, Brussels is moving forward and this is an extremely welcome approach, however, a European strategy is required for the development of highly needed drugs against COVID-19 as well. At the European Alliance Against Coronavirus meeting in early February 2021, stakeholders like BioM advocated for more engagement from Europe in the fight against COVID-19 through effective therapeutics. Already since the beginning of the pandemic, BioM, as the management organisation for the Munich Biotech Cluster, called for more financial support for R&D of drugs against COVID-19 – and was ultimately successful in the Bavarian state parliament: at the end of 2020, the Bavarian funding program “BayTherapie2020” worth €50m was launched. Currently, 25 therapeutics projects are in the evaluation process. Triggered by this, the federal government followed suit shortly afterwards with a €50m funding program. However, these amounts are far from sufficient to conduct clinical trials with drug candidates, especially in Phase III of their development. Further funding initiatives such as these – also from Europe – are therefore needed.

Risk due to mutations

Especially considering the growing challenge associated with SARS-CoV-2 mutants, Prof. Dr Clemens Wendtner, Chief physician of infectiology at Munich Schwabing clinic, who treated with his team the first COVID-19 patients in Germany in January 2020, is calling for more funding for drug development: “We observe mounting evidence that the SARS-CoV-2 mutant B.1.1.7. is not only more contagious, but also carries an increased risk of a severe and fatal progression. In addition, the viral variants from South Africa and Brazil represent a growing problem: studies using pseudoviruses with corresponding mutations showed reduced neutralising activity of antibody drugs. I, therefore, see an increased medical need for the funding and development of effective therapeutics not least with respect to a partially moderate vaccination rate”. Beyond that, Prof. Dr Michael Bergwelt, Director of the Medical Clinic and Polyclinic III at the LMU University Hospital Munich, fears limited effectiveness of the vaccination strategy due to vaccination refusers or insufficient immune responses, especially in high-risk patients, as an imperative reason for therapeutic developments. Bavaria has decided to support the development of innovative anti-
COVID-19 drugs by a financial contribution of €50m. Why the EU should not become a second follower with a contribution of €1bn – or even more?

This text was originally published in the European Biotechnology Magazine Spring 2021.