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Karliczek: Advance research now so that COVID-19 drugs reach people quickly
In addition to the availability of vaccines and a targeted test strategy, safe and effective drugs against SARS-CoV-2 are crucial in order to be able to cope with the pandemic. Against this background, the Federal Ministry of Education and Research (BMBF) is promoting promising approaches to drug development in local research institutions and companies and is promoting drug research against COVID-19. For this purpose, the BMBF has now received the first funding recommendations for eight projects within the framework of the funding program “Research and development of urgently needed therapeutics against SARS-CoV-2” by an independent, scientific review committee. Projects from pharmaceutical and biotechnology companies as well as other scientific associations under industrial coordination are to be funded whose preclinical developments are far enough advanced to transfer their drug candidates to clinical trials. Federal Research Minister Anja Karliczek explains:
“We are at an important crossroads in the corona pandemic: The vaccination campaign is gaining speed. Test possibilities are increasing. At the same time, we are concerned about the continued high number of infections and increasing occupancy in hospitals. Unfortunately, we must also expect that people will continue to contract COVID-19 in the future - with very severe and less severe disease courses.
We therefore urgently need more effective drugs to treat the sick. However, there will be no “one pill” against COVID-19. Because depending on the severity and stage of the disease, patients need different therapy. It is therefore important to expand the treatment repertoire as required and to strengthen promising drug developments.
We have seen since the outbreak of the new corona virus: Research is a central key in combating the pandemic. The BMBF has been providing funding to combat SARS-CoV-2 since the beginning of the pandemic. I am therefore very pleased that we can now continue to support promising approaches in drug research and jointly advance the clinical development of drug candidates.
The researchers' drug candidates rely on various technologies and treatment approaches to influence the course of the disease. One approach is based, for example, on a small chemical molecule, a so-called kinase inhibitor, which addresses factors in the body cell that are also crucial for virus replication. According to the research results so far, this works against both the virus and an excessive inflammatory reaction. A second bright spot are monoclonal antibodies, which serve the immune system and, with their specific structure, can have a neutralizing effect on the virus itself in order to slow it down. However, other antibodies can also be directed against signal substances that intensify the disease and thus also dampen virus-induced disturbances in the body and thereby improve organ functions again. The researchers also expect success from an RNA active ingredient, the structure of which enables the specific binding of inflammatory messenger substances and is thus intended to help limit the immune reaction and damage to organs.
With these and other projects, we will advance research so that new drugs against COVID-19 reach patients quickly. But we won't be there yet. It takes our combined efforts to advance the development of effective medicines. As part of the assessment, it became clear that some good projects also need a little more time to meet the funding requirements for the measure. We are therefore planning to allow a second submission deadline in the summer of this year. "
The aim of the funding program for “research and development of urgently needed therapeutics against SARS-CoV-2” is to strengthen the clinical development of promising therapeutic approaches against COVID-19. On the one hand, this concerns the clinical testing of drug candidates that are explicitly directed against SARS-CoV-2. On the other hand, there is also a need for the clinical development of new therapeutic approaches for the treatment of severe disease courses in COVID-19 - for example, those that counteract an excessive immune reaction. The principle of action for the treatment of COVID-19 must be proven in both cases by comprehensive preclinical data.
The subject of funding is the clinical trials of phases I - IIb in order to enable sufficiently reliable conclusions to be drawn about a positive risk-benefit ratio for accelerated approval. The work required to manufacture investigational medicinal products is then carried out in accordance with the guidelines of Good Manufacturing Practice (GMP). Companies in the commercial sector that have a permanent establishment in Germany at the time of funding and small associations with appropriate industrial coordination are eligible to apply.
The announcement started on January 6, 2021. Applications could be submitted until February 17. The BMBF made the funding decision with the involvement of external experts as part of a one-stage process. Representatives from clinical research, science, the pharmaceutical industry and regulatory authorities were appointed to the committee. The latest end of the project term is December 31, 2023. The funding is subject to European state aid law.
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