19 November 2020
Pfizer and BioNTech announced the final efficacy analysis of their ongoing Phase III study of BNT162b2, their mRNA Covid-19 vaccine candidate. The analysis found the efficacy rate to be 95% among individuals seven days after receiving the second dose. As a result, the partners plan to file for an emergency use authorisation (EUA) in the US in the next few days.
BioAegis Therapeutics and EastHORN Clinical Services have expanded their Phase II clinical trial of rhu-pGSN for treating severe cases of Covid-19, which was initiated by EastHORN in Spain in August. The Romanian National Agency for Medicines and Medical Devices (NMMD) has approved the extension of the trial into Romania; the first patients will be recruited this week.
Relief Therapeutics selected Syneos Health, a global clinical research organisation, and AMRI, a global contract development and manufacturing organisation, to run clinical trials of its drug RLF-100 for severe Covid-19 cases in Europe, as well as manufacture the product in the UK. Clinical assessment of RLF-100 in Europe is expected to begin in the first quarter of 2021.
Adagio Therapeutics has submitted a data showing its Covid-19 antibody, ADG2, demonstrated high potency against the SARS-CoV-2 virus, compared to monoclonal antibodies in clinical development. ADG2 also achieved broad neutralisation against a range of other dangerous sarbecoviruses. Adagio expects its lead antibody, ADG20, to enter clinical studies for Covid-19 in early 2021.