Gilead halts COVID-19 remdesivir trial due to enrolment issues, efficacy of the drug uncertain
pharmafile | April 16, 2020 | News story | Research and Development | COVID-19, Gilead, coronavirus, pharma, remdesivir
A clinical trial in China investigating Gilead’s antiviral therapy remdesivir as a potential treatment for COVID-19 has been placed on hold after it failed to enrol an adequate number of participants, sending the company’s shares down by 3%.
The Phase 3 trial sought to determine the drug’s efficacy in mild to moderate cases of COVID-19 in hospitalised patients, with time to clinical recovery being the primary measure of success. It was thought that the drug could provide more benefit in this patient population than in more severe cases.
This is the second remdesivir trial to be suspended after a study of the drug in more severe COVID-19 cases was halted less than a week earlier because of problems recruiting enough patients. Gilead is currently trialling the therapy against the disease in at least five clinical trials.
Gilead has so far supplied remdesivir to over 1,800 affected patients on a compassionate use basis. Data published in the New England Journal of Medicine suggested that 53 such patients had shown promising results, but the lack of controls in the trial mean that the benefit cannot be judged definitively at this stage.
The patients, based in China, Europe and the US, were given the drug for up to 10 days, with 68% showing improvement and 17 of 30 patients on ventilators able to be taken off them.
Brian Abrahams, an analyst at RBC Royal Bank, gave his evaluation of the drug’s efficacy based on available data so far: “We continue to believe that while remdesivir showed a promising signal of activity in the recent open label compassionate use published data, the fact that no data has been revealed from the truncated severe study in China—the only randomized study thus far—despite today’s update also indicated it had enrolled a reasonably robust number of patients (n=237), suggests any benefits observed were likely inconclusive and maintains our view that the likelihood of remdesivir demonstrating substantial activity remains at best 50/50.”
Among its ongoing COVID-19 studies, Gilead has two Phase 3 trials investigating the efficacy of remdesivir in countries with high prevalence of the disease, with results expected to be published in May.
Matt Fellows
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