Hungary Starts Clinical Trials for COVID-19 Drug

Hungarian health authorities have given green light to the clinical trial of a coronavirus drug manufactured by local pharmaceutical company Richter Gedeon. The drug containing the antiviral agent remdesivir may thus become available to Hungarian patients. Remdesivir is the most effective drug known to date in the treatment of coronavirus infections.

Hungary’s largest drug maker, Richter Gedeon has launched local production of one of the most effective drugs against the coronavirus at full speed. Following five months of painstaking research, experts at Richter have managed to synthetize remdesivir, the most promising antiviral agent used in the treatment of patients suffering from coronavirus infection. US President Donald Trump was also treated with remdesivir after he tested positive for COVID-19.
The European Commission announced in July that it had authorized the conditional marketing of a medicine called Veklury, which contains the active substance remdesivir, for the treatment of severe coronavirus infections. Coronavirus patients who had been on ventilator recovered after approximately 11 days following treatment with the drug, according the EU data.

Proven efficiency
International research has shown that the drug is highly effective against the coronavirus, reducing the risk of death by up to 50%. Remdesivir is the first clinically proven agent to accelerate patient recovery and consistently reduce the mortality rate, Zsuzsa Beke, communications director at Richter told news portal index.hu. Conducting clinical trials, however, is not Richter's responsibility; it is up to health authorities to orchestrate this process. Under an agreement signed with the government in the spring, Richter hands over the drugs that it produces to the state and the medicine is not available for sale in pharmacies.
The announcement that clinical trials can commence comes as the second wave of the pandemic is engulfing Hungary and the number of confirmed cases and deaths is rising steeply. By October 15, Hungary has recorded a total of 41,732 people with confirmed coronavirus infection since the start of the pandemic, and 1,052 have succumbed to the illness, according to official government figures. Prime Minister Viktor Orbán warned in early October that the pandemic is set to deteriorate over the coming months and a vaccine was not likely to be developed before the summer of 2021.

Clinical trial
Seven universities and institutes have been granted approval to start clinical trials of the drug, including the University of Szeged, Semmelweis University in Budapest, the University of Debrecen and the University of Pécs, as well as the South Pest Center Hospital, the National Korányi Institute of Pulmonology and Szent János Hospital, the latter two located in the capital. The drug will be administered to patients who have already reached the age of 12 and whose condition is moderate or severe. The selected patients will receive the drug in the form of an infusion for 5-10 days. The drug needs to pass several clinical trial phases before it can be widely used.

Fighting the virus on many fronts
Richter is currently working on five research and development projects that are aimed at the development or large-scale production of therapies for the treatment of coronavirus patients. The company works together with experts from various universities across the country and receives financial support from the state for some of the projects. In addition to the remdesivir development, Richter is also a member of a consortium working on the domestic development of the Japanese active substance favipiravir. This project is currently underway and Richter assists the research in the field of active ingredient manufacturing. The company is also active in a biosimilar drug development called tocilizumab. Zsuzsa Beke emphasized that tocilizumab is primarily used for the treatments in the field of rheumatology, but it may also be administered to COVID patients who show inflammatory symptoms as a result of the viral infection. The Budapest-based company is also involved in the production of a coronavirus vaccine through its joint venture with Helm AG. They reached an agreement in April with US-registered INOVIO to manufacture a DNA-based vaccine. This vaccine is currently under development and is expected to enter phase 3 of the clinical trial before the end of the year.