Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #20.11

Remdesivir trials on hold in China

Having to stop the development of a clinical candidate because the disease seems to disappear while studies are ongoing is one of the most awkward situation a biopharmaceutical company can face. And this is precisely what Gilead is going through right now with remsedivir, its antiviral agent, in China. Less than a week after the American biotechnology company had to stop to test its drug in severe cases of COVID-19 in Chinese patients, because of poor enrolment, Biogen now had to halt enrolment in patients with a milder form of the disease. Just after the outbreak of the epidemic of COVID-19 in the Wuhan region, remedesivir was selected as the very first antiviral agent to be tested in China, with full approval and support of the Chinese health authorities. In an update of April 14, 2020 of ClinicalTrials.gov, the ongoing remdesivir trial being undertaken in China is now registered as:

“Suspended”: The epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruited”.

The latest clinical trial was recruiting mild to moderate forms of patients eligible for hospital care with a primary outcome being time to clinical recovery, which was set for up to 28 days. The secondary endpoint was overall mortality. Both studies in China are now on hold because of missing COVID-19 patients.

Earlier this month Gilead had reported preliminary results, in the New England Journal of Medicine on the experiences of compassionate treatments in 61 patients, in an analysable cohort of 53 patients. The lack of a control arm made it very difficult to interpret the data.

Gilead is still conducting studies with remdesivir with the US National Institute of Allergy and Infectious Diseases and in Europe with the Discovery trial under the INSERM sponsorship.

In case of a positive outcome results should be available before the end of this month.

Paris April 16, 2020

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