The pharmaceutical company AstraZeneca will conduct the second phase of a pre-registration study of a new drug for the prevention of coronavirus in Russia, according to the register of clinical trials of the Ministry of Health.
According to the data, approval for the study of the drug with the name AZD3152 was issued in August 2023. The trials are being conducted from September 30, 2023 to June 7, 2024, AstraZeneca says on its website. It is expected that the study participants will be 130 people with reduced immune status aged 18 to 99 years. Permission for the study was issued to the Russian legal entity Astrazeneca Pharmaceuticals.
Kommersant notes that this will be the second local AstraZeneca study that has received permission this year. The companies previously approved a phase 2 trial of the combination of the yet-unregistered ceralasertib with durvalumab in patients with non-small cell lung cancer. It is also sponsored by a Russian structure.
The head of scientific examination of the venture fund LanceBio Ventures, Ilya Yasny, explained to the newspaper that AstraZeneca wants to remain on the Russian market, and conducting local research is an acceptable way, since international testing requires the export of biosamples abroad, and the EU and US regulator must have access to any research center , which would be difficult now.
DSM Group CEO Sergei Shulyak emphasized that pharmaceutical companies do not want to lose the Russian market. At the same time, AOKI Executive Director Svetlana Zavidova notes that AstraZeneca’s initiative for local research is an isolated case, and other Western companies are not active.
Against the backdrop of Russia’s special operation in Ukraine, international pharmaceutical companies, including Roche, GSK, Novartis, Pfizer, suspended new clinical trials in the Russian Federation, and also stopped recruiting patients for current ones. AstraZeneca’s statement also said the company is not starting “global clinical trials” in Russia and is focused on supplying life-saving .