Less than 12 hours after I reported positive news about remdesivir, Gilead stock took a hit because the company terminated a COVID-19 trial of remdesivir in China due to lack of enrollment. As first noted on Endpoints News, this does not mean the drug didn’t work, just that they were not able to enroll adequate numbers of patients. Analysts always wonder if this is due to a perceived lack of efficacy. The major clinical trial in the US is due out in May. That will decide the drug’s fate.
What follows is the text of the Endpoints alert. I recommend you sign up for their free access if you’re interested in Pharma or Biotech.
Gilead takes a hit after quietly terminating a closely-watched Covid-19 trial of remdesivir
Shares of Gilead took a 3% hit $GILD Wednesday after the big biotech noted that it had suspended one of its closely-watched Covid-19 studies for remde-sivir in China. Initially highlighted in a note from RBC Capital, Gilead stated in an update on clinicaltrials.gov today that their Phase III for mild to moderate patients had to be terminated due to a lack of patients to enroll.
The epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruited.
As senior RBC biotech analyst Brian Abrahams noted, they’re continuing to look for results from the trial in severe patients, and possibly the data gath-ered from the terminated study as well.
(K)ey upcoming readouts for the drug remain the GILD-sponsored studies in severe (late April, though lack of a control arm may limit interpretability) and moderate (May) COVID-19 patients. NIAD’s remdesivir data may also come as early as May.
But Abrahams adds that this new development in a trial designed to enroll more than 300 patients is likely to further cause doubt that remdesivir can of-fer significant help to patients.
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 indicating it had enrolled a reason ably robust number of pts (n=237), suggests any bene!ts observed were likely inconclusive and maintains our view that the likelihood of remdesivir demonstrating substantial activity remains at best 50/50.
Remdesivir is the most advanced of all the antivirals in the clinic for the virus which has caused global havoc as the death toll continues to mount around the planet. Repurposed from Ebola, Gilead has put a bright spotlight on the drug and its plans to accelerate development timelines in a race to find something to counter the pandemic. Those plans include ramping up produc-tion of remdesivir in anticipation of huge global demand for the drug.
Gilead has become something of a punching bag for the analysts as they divvy up into optimists and skeptics on remdesivir’s chances as they approach a series of catalysts. The company recently published data from compassionate use patients which they termed — with important caveats — as encouraging. The data itself were largely useless though compared to a ran-domized study with a control arm, where researchers have a much better chance of capturing success or failure in treating patients.
A success may go a long way to calming the turmoil around the pandemic, which has claimed more than 128,000 lives. A failure would likely cause consid-erable angst at the prospect of waiting longer for something to prove itself ef-fective.
Gilead — which has had its shares of praise and criticism in how it’s handled communications on remdesivir — did not respond immediately to a query of mine.