Developer of the coronavirus experimental treatment, Gilead Sciences, said the drug, Remdesivir, has generated “positive data” in a trial of the antiviral organised by the National Institute of Allergy and Infectious Diseases (NIAID).
“We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing,” Gilead said in a statement Wednesday.
A Gilead recent document on its website disclosed that the NIAID study is a double-blind placebo-controlled trial encompassing over 800 patients, and involves patients with critical, severe and moderate Covid-19 systems.
Following the news, Gilead’s shares rose by over 4 per cent Wednesday morning. The company’s Chief Executive Officer, Daniel O’Day, had explained in an April 4 open letter that multiple clinical trials have been set up to determine the safety and effectiveness of remdesivir for Covid-19 treatment.
Gilead said it would share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe Covid-19 disease shortly, even O’Day disclosed that NIAID and the World Health Organisation (WHO) were running global trials.
“This study will provide information on whether a shorter, five-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials,” the statement added.
“Gilead expects data at the end of May from the second SIMPLE study evaluating the five and 10-day dosing durations of remdesivir in patients with moderate Covid-19 disease.”
However, remdesivir is still awaiting regulatory approval as a coronavirus treatment in the U.S. The antiviral was previously used to treat Ebola patients and has been garnering massive attention as the world scrambles to contain the coronavirus pandemic.
Experts, however, have warned that people should not take drugs unless prescribed by a doctor. The various trials of remdesivir have come under intense scrutiny, even as it failed to show benefits in a trial in China, according to reports last week.
Citing draft documents accidentally published by WHO, the Financial Times said the study was the first randomised clinical trial of the antiviral to treat coronavirus.
Also reporting on the document, STAT noted that the data from the study were likely imperfect, adding that the trial was ended prematurely, which could have affected the results.
On their part, a Gilead Sciences spokesperson said in a statement at the time that the WHO documents “included inappropriate characterisations” of the study.
China was also said to have suspended two clinical trials for remdesivir because the “epidemic (Covid-19) has been controlled well at present,” according to reports earlier this month, while an April 15 notice on the U.S. National Library of Medicine’s ClinicalTrials website said the trials were postponed as “no eligible patients can be recruited.”
- Culled and edited from Fox News
Leave a Reply