1 July 2020
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted authorisation for researchers to resume enrolment in the COPCOV trial. This trial is designed to assess hydroxychloroquine and chloroquine to potentially prevent Covid-19 in healthcare workers. The trial was paused after hydroxychloroquine failed to demonstrate benefit in another UK trial involving patients infected with Covid-19.
Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. The vaccine candidate was found to be generally safe and well-tolerated in all participants, as well as demonstrated overall immunological response rates in 94% of participants.
Eisai, in alliance with the Global Coalition for Adaptive Research (GCAR) and University of Pittsburgh Medical Center (UPMC), is set to assess its experimental TLR4 antagonist Eritoran as part of the REMAP-COVID study. Eritoran is the first immune modulation therapy candidate selected to treat moderate Covid-19 patients in the REMAP-COVID study.
The US Food and Drug Administration (FDA) has released guidance with recommendations for the manufacturing, clinical development and approval of a Covid-19 vaccine. While the development and review processes are being accelerated in the wake of the ongoing pandemic, the FDA will require certain data to be submitted to meet its regulatory standards.
Japanese pharmaceutical startup AnGes has initiated clinical trial of a Covid-19 vaccine candidate, marking the first human study of a potential coronavirus vaccine in the country. The trial will involve 30 healthy adults at Osaka City University Hospital. If positive safety data is obtained, the vaccine will be evaluated in approximately 500 additional participants.