Remdesivir Update

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 epi​dem​ic of COVID-19 has been con​trolled well at present, no el​i​gi​ble pa​tients can be re​cruit​ed. 

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 up​com​ing read​outs for the drug re​main the GILD-spon​sored stud​ies in se​vere (late April, though lack of a con​trol arm may lim​it in​ter​pretabil​i​ty) and mod​er​ate (May) COVID-19 pa​tients. NI​AD’s remde​sivir da​ta may al​so come as ear​ly 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 con​tin​ue to be​lieve that while remde​sivir showed a promis​ing sig​nal of ac​tiv​i​ty in the re​cent open la​bel com​pas​sion​ate use pub​lished da​ta, the fact that no da​ta has been re​vealed from the trun​cat​ed se​vere study in Chi​na — the on​ly ran​dom​ized study thus far — de​spite to​day’s up​date al​so in​di​cat​ing it had en​rolled a rea​son​ ably ro​bust num​ber of pts (n=237), sug​gests any ben​e​!ts ob​served were like​ly in​con​clu​sive and main​tains our view that the like​li​hood of remde​sivir demon​strat​ing sub​stan​tial ac​tiv​i​ty re​mains 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.