RNATICS granted € 7 million for the clinical development of a new COVID-19 drug

Federal Ministry of Education and Research funds clinical testing of RCS-21.

rnatics is developing RCS-21, an RNA-based compound to prevent inflammatory lung damage in COVID-19 patients based on its unique macrophage targeting technology. The detrimental tissue damage occurs particularly in a severe course of COVID-19. The Federal Minister of Education and Research (BMBF) Stark-Watzinger announced rnatics as one of three winners of the national competition for new COVID-19 drugs and is supporting the further development of the rnatics drug with € 7 million euros. The therapy is expected to be efficacious in current and future mutations of SARS-CoV2.

Severe lung inflammation and scarring of the lung tissue are typical consequence of COVID-19. They can limit lung function in the long term and are one of the causes of “Long COVID”. A team led by Stefan Engelhardt, Professor of Pharmacology and Toxicology at TUM, has developed a new targeted RNA compound to prevent inflammatory lung damage.
When administered via inhalation to the respiratory tract, the substance binds specifically to and is rapidly taken up by immune cells in the alveoli, where it inhibits a specific microRNA. In COVID-19, misdirected immune cells – macrophages – contribute significantly to the formation of excessive inflammation and lung damage. However, when the microRNA molecule was specifically blocked by RCS-21 in mice, significantly less inflammation and lung damage occurred, and lung function improved markedly. Stefan Engelhardt is confident that serious inflammation, and ultimately lung damage, can also be prevented in humans with COVID-19 who inhale the compound.

We then plan to enter phase 1 of the clinical trial in about a year from now

Klaus Rabe, co-founder of rnatics

Based on the active substance RCS-21, rnatics is now developing an inhalation treatment for COVID-19 disease. The RNA drug would be the first in its class to be specifically taken up by macrophages. “By affecting immune cells rather than the virus, RCS-21 should also be effective in diseases caused by Omicron or future, more aggressive virus variants” says Deepak Ramanujam, co-inventor of the approach. The Federal Ministry of Education and Research (BMBF) will fund the clinical trials for the drug with € 7 million as part of the program “Promotion of Research and Development of Urgently Needed Therapeutics against SARS-CoV-2”. Further, ISAR Bioscience GmbH will support the development of RCS-21.

The Federal Institute for Drugs and Medical Devices (BfArM) has already given a positive assessment for RCS-21 in an advice meeting – an important condition for the final development of a drug. CEO and co-founder Thomas Frischmuth expects rnatics to be able to complete the preclinical toxicological assessment in the third quarter of 2022. “We then plan to enter phase 1 of the clinical trial in about a year from now” says Klaus Rabe, co-founder of rnatics. In this first of three clinical phases before approval, the safety of a drug administered to a small group of people is assessed.