Coronavirus company news summary – EC authorises Roche-Regeneron’s Covid-19 antibody combination - Appili’s Covid-19 antiviral fails Phase III trial
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Coronavirus company news summary – EC authorises Roche-Regeneron’s Covid-19 antibody combination – Appili’s Covid-19 antiviral fails Phase III trial

15 Nov 2021

Roche and Regeneron have obtained marketing authorisation from the European Commission (EC) for their antibody combination therapy, Ronapreve, to prevent and treat Covid-19 in individuals aged 12 years and above. Ronapreve is indicated for Covid-19 patients who do not need supplemental oxygen but are at high disease progression risk. The approval comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval based on positive results from two Covid-19 trials of the therapy.

Appili Therapeutics has reported that its Covid-19 oral antiviral tablet, Avigan/Reeqonus (favipiravir) failed the Phase III PRESECO clinical trial. Data showed that the trial failed to attain statistical significance on the primary goal of time to sustained clinical recovery. The double-blind, placebo-controlled, randomised trial assessed the safety and efficacy of oral tablets in Covid-19 outpatients. A total of 1,231 subjects suffering from mild-to-moderate Covid-19 were enrolled at 38 trial centres across the US, Mexico and Brazil. Further assessment of the results from the trial is underway, the company noted.

Innovation Pharmaceuticals has reported that the firm is carrying out a complete assessment of data from the Phase II Covid-19 clinical trial of Brilacidin to include the drug in Covid-19 platform clinical trials sponsored by various governments. The CTAP programme of the UK government and the ACTIV programme of the US National Institutes of Health focus on identifying potential therapies for Covid-19. In addition, the latest data from in vitro study showed that Brilacidin acts on viral proteins as well as host factors, indicating that the drug is less likely to acquire resistance as against other antiviral therapies.