Remdesivir Update

Remdesivir awaits clinical validation as a treatment for COVID-19.

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 af​ter qui​et​ly ter​mi​nat​ing a close​ly-watched Covid-19 tri​al of remde​sivir

Shares of Gilead took a 3% hit $GILD Wednes​day af​ter the big biotech not​ed that it had sus​pend​ed one of its close​ly-watched Covid-19 stud​ies for remde-​sivir in Chi​na. Ini​tial​ly high​light​ed in a note from RBC Cap​i​tal, Gilead stat​ed in an up​date on clin​i​cal​tri​als.gov to​day that their Phase III for mild to mod​er​ate pa​tients had to be ter​mi​nat​ed due to a lack of pa​tients to en​roll. 

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

As se​nior RBC biotech an​a​lyst Bri​an Abra​hams not​ed, they’re con​tin​u​ing to look for re​sults from the tri​al in se​vere pa​tients, and pos​si​bly the da​ta gath-​ered from the ter​mi​nat​ed 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 Abra​hams adds that this new de​vel​op​ment in a tri​al de​signed to en​roll more than 300 pa​tients is like​ly to fur​ther cause doubt that remde​sivir can of-​fer sig​nif​i​cant help to pa​tients. 

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. 

Remde​sivir is the most ad​vanced of all the an​tivi​rals in the clin​ic for the virus which has caused glob​al hav​oc as the death toll con​tin​ues to mount around the plan​et. Re​pur​posed from Ebo​la, Gilead has put a bright spot​light on the drug and its plans to ac​cel​er​ate de​vel​op​ment time​lines in a race to find something to counter the pan​dem​ic. Those plans in​clude ramp​ing up pro​duc-​tion of remde​sivir in an​tic​i​pa​tion of huge glob​al de​mand for the drug. 

Gilead has be​come some​thing of a punch​ing bag for the an​a​lysts as they divvy up in​to op​ti​mists and skep​tics on remde​sivir’s chances as they ap​proach a se​ries of cat​a​lysts. The com​pa​ny re​cent​ly pub​lished da​ta from com​pas​sion​ate use pa​tients which they termed — with im​por​tant caveats — as en​cour​ag​ing. The da​ta it​self were large​ly use​less though com​pared to a ran-​dom​ized study with a con​trol arm, where re​searchers have a much bet​ter chance of cap​tur​ing suc​cess or fail​ure in treat​ing pa​tients.

A suc​cess may go a long way to calm​ing the tur​moil around the pan​dem​ic, which has claimed more than 128,000 lives. A fail​ure would like​ly cause con​sid-​er​able angst at the prospect of wait​ing longer for some​thing to prove it​self ef​-fec​tive. 

Gilead — which has had its shares of praise and crit​i​cism in how it’s han​dled com​mu​ni​ca​tions on remde​sivir — did not re​spond im​me​di​ate​ly to a query of mine. 

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

2 thoughts on “Remdesivir Update

  1. I wonder if the lack of interest in participating in a pharma-drug trial could simply mean that they would rather rely on Traditional Chinese Medicine? A trial in the USA might be better received?

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