BMBF: Additional millions for therapeutics against COVID-19

04 Jan 2022

BMBF: Additional millions for therapeutics against COVID-19

Shortly before Christmas, the new Federal Minister of Research Bettina Stark-Watzinger (FDP) awarded around 24 million euros to three German therapeutics companies for the development of projects against COVID-19: Evotec, Proteo Biotech and rnatics.

It took until mid-May 2021 for the German Federal Ministry of Education and Research (BMBF) and the German Federal Ministry of Health to jointly establish a funding program for developers of therapeutics against COVID-19, the scope of which corresponds to expensive clinical development processes. The program, which was originally funded by the BMBF alone with only 50 million euros in January of last year, and which was also aimed almost exclusively at academic project groups, had been heavily criticized. Most industry representatives were more pleased with the joint funding program and its volume of 300 million euros.

Following a series of approvals of drugs that directly target the virus itself and should be used in the early stages of infection, when possible (Merck, Pfizer, GSK/Vir, Roche/Regeneron ...), the pressure on the therapy side seems to be easing somewhat. However, not all drugs are officially approved and available in Germany. There remains a clear need for action in the clinical care of COVID-19 patients, particularly in severe disease courses with organ-spanning complications and prolonged inflammatory responses that are triggered by the virus and can become systemic.

The three projects currently selected by the BMBF are therefore from the field of "concomitant diseases" with quite serious courses and do not directly target the virus or virus parts. Federal Minister Stark-Watzinger underlined the importance of therapeutics and said at the announcement: "We need effective and safe drugs so we can treat patients at all stages of the disease. As the Ministry of Research, we will continue to promote the development of high-potential corona therapeutics, always keeping in mind the efficacy against new viral mutations."

These projects are now receiving increased funding from the BMBF:

The goal of Proteo Biotech AG's research project is to demonstrate the efficacy and safety of the human protein Elafin for the treatment of COVID-19 in a clinical trial. The focus is on preventing severe disease progression as well as organ complications in severe COVID-19 disease due to an excessive immune response. The protein is a recombinant protein found in the human body, where it has an anti-inflammatory effect. The company has been researching this effect in various lung diseases for several years (funding amount around 10 million euros).

In the CoVmiR project of rnatics GmbH, a drug for the inhaled treatment of inflammatory lung damage in COVID-19 is being tested in a clinical trial, which inhibits a microRNA in macrophages. This microRNA promotes the inflammatory process and is found in very high concentrations in lungs of individuals suffering from COVID-19. This leads to pathological changes in lung tissue during advanced disease progression. The goal is to complete the clinical phase I development (including a first-in-man application in COVID-19) and thus lay the groundwork for the conduct of a subsequent phase II trial (funding amount approximately EUR 7 million).

Evotec International GmbH's research project intends to conduct a Phase I and IIa clinical trial to demonstrate the safety and efficacy of a novel immunomodulatory molecule (EVT075) in COVID-19 patients. Preclinical in vitro studies demonstrated a stronger induction of the immune system's antiviral response than comparable molecules in previously conducted studies. Early administration of the immunomodulatory molecule makes it possible to reduce the viral load and thus the risk of severe disease progression (funding amount 7.5 million euros).

Commenting on the funding decision, Dr. Werner Lanthaler, CEO of Evotec, said, "The start of the third pandemic year has once again highlighted the urgent need for effective drugs to treat COVID-19, in addition to further immunization with vaccines."