With some new drugs having started clinical testing in COVID-19 patients in the last few days, and more news on clinical results and regulatory filings, here’s a round-up of recent developments:
– Gilead Sciences has filed for approval of its front-runner antiviral for COVID-19 – remdesivir – with the EMA, which has said it will fast-track its review and the drug could be available within a few weeks. The regulator started a rolling review of remdesivir, which has been shown to cut around four days off the recovery time in severe COVID-19 cases, in April.
– Chinese biotech Junshi Biosciences has started dosing patients in the first human trial of JS016, a neutralising antibody against SARS-CoV-2, the virus that causes COVID-19. The antibody is partnered with Eli Lilly, which began trials in the US of another neutralising antibody candidate – AbCellera-partnered LY-CoV555 – last week. Lilly has said it will start testing JS016 in US patients within the next few days.
– The first clinical results with AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) in hospitalised COVID-19 patients has found preliminary evidence that the drug reduced inflammation and improved clinical outcomes in severely-ill cases. The data – published in the journal Science Immunology – come from 19 patients with severe respiratory illness caused by the SARS-CoV-2. AZ is currently conducting two phase 3 trials of Calquence in COVID-19.
– The results from the large-scale RECOVERY trial run by the University of Oxford in the UK have come in for the hydroxychloroquine arm, and concluded the drug has no benefit when given to patients hospitalised with COVID-19. One of the lead investigators – Prof Martin Landray – said that the result is important because after all the hyperbole about hydroxychloroquine it is now confirmed as “useless” and should not be used. Other trials are still ongoing – including the World Health Organisation’s Solidarity study and COPCOV, led by the Mahidol Oxford Tropical Medicine Research Unit in Bangkok.
– Japan’s Daiichi Sankyo has teamed up with Nichi-Iko Pharma, the University of Tokyo and the RIKEN research institute to start development of an inhaled formulation of serine protease inhibitor nafamostat – sold as Futhan to treat acute pancreatitis – as a COVID-19 therapy. Preclinical studies suggest the drug may be able to block the entry of SARS-CoV-2 into cells, and clinical trials could start next year after reformulation work, say the partners.
– US medicinal cannabis company FSD Pharma has been given a green light by the FDA to submit an Investigational New Drug (IND) application for FSD-201 (ultramicronised palmitoylethanolamide, or PEA) to treat coronavirus patients. The company says FSD-201’s anti-inflammatory properties make it a potential treatment for the cytokine storm associated with acute lung injury in hospitalised COVID-19 patients.