28 April 2020
Moderna is seeking approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial of its Covid-19 vaccine candidate, mRNA-1273, if positive safety is obtained in the Phase I study. The Phase II trial is set to begin in the second quarter of this year in around 600 healthy volunteers.
Japan will soon approve Gilead Sciences’ anti-viral drug remdesivir, which is currently in clinical trials, to treat Covid-19, according to Kyodo News citing Prime Minister Shinzo Abe at a parliamentary session. Gilead is yet to submit an application to the Japanese government, which is expected to fast-track the approval process and perform domestic studies later.
Merck has entered into a research collaboration with the Institute for Systems Biology (ISB) to study molecular mechanisms of Covid-19 infection and identify targets for drugs and vaccines. Merck also signed another agreement for funding support from the US Biomedical Advanced Research and Development Authority (BARDA).
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide $3.5m funding for Clover Biopharmaceuticals to support the preparation and launch of a Phase I trial of its protein-based Covid-19 S-Trimer vaccine in Australia. Clover is the ninth organisation to receive CEPI support and funding for Covid-19 vaccine candidates.
Humanised monoclonal antibody drug leronlimab has shown ‘impressive results’ in a small observational Covid-19 study, said the drug’s developer HIV pharma company CytoDyn CEO Dr Nader Pourhassan in a conference call. Diagnostic firm IncellDX CEO Dr Bruce Patterson also noted that the drug decreased plasma viral load and restored immune cells; IncellDX’s lab analysed blood samples of the first ten patients in the Covid-19 trial.