It may be the end of the road for colchicine, an in­ex­pen­sive oral an­ti-in­flam­ma­to­ry drug com­mon­ly used to treat gout, as a po­ten­tial Covid-19 treat­ment — at least in hos­pi­tal­ized pa­tients.

The UK’s RE­COV­ERY tri­al put out the word on Fri­day that it’s halt­ing en­roll­ment in its colchicine study af­ter a da­ta mon­i­tor­ing com­mit­tee saw “no con­vinc­ing ev­i­dence that fur­ther re­cruit­ment would pro­vide con­clu­sive proof of worth­while mor­tal­i­ty ben­e­fit ei­ther over­all or in any pre-spec­i­fied sub­group.”

In a pre­lim­i­nary analy­sis of 11,162 pa­tients ran­dom­ized to re­ceive ei­ther colchicine or stan­dard care alone, there was no sig­nif­i­cant dif­fer­ence in the pri­ma­ry end­point of 28-day mor­tal­i­ty, ac­cord­ing to re­searchers. The mor­tal­i­ty rate was 20% in the colchicine group ver­sus 19% in the usu­al care group. The fi­nal re­sults will be pub­lished “as soon as pos­si­ble,” ac­cord­ing to a state­ment.

The RE­COV­ERY tri­al was es­tab­lished to test a range of po­ten­tial treat­ments for Covid-19. Re­cruit­ment to all the oth­er treat­ment arms — in­clud­ing as­pirin, baric­i­tinib, Re­gen­eron’s an­ti­body cock­tail, and (in se­lect­ed hos­pi­tals) di­methyl fu­marate — will go forth as planned.

“We do large ran­domised tri­als to es­tab­lish whether a drug that seems promis­ing in the­o­ry has re­al ben­e­fits for pa­tients in prac­tice,” Ox­ford Uni­ver­si­ty and joint chief in­ves­ti­ga­tor Mar­tin Lan­dray said in a state­ment. “Un­for­tu­nate­ly, colchicine is not one of those.”

RE­COV­ERY tri­al up­date:

Colchicine arm stopped for lack of ef­fi­ca­cy in pa­tients hos­pi­talised with COVID-19.https://t.co/hcn9PytegJ pic.twit­ter.com/q09ed­dYXYL

— Mar­tin Lan­dray (@Mar­tin­Lan­dray) March 5, 2021

The news comes just over a month af­ter Mon­tre­al re­searchers read out some con­tro­ver­sial da­ta on colchicine’s ef­fect as a Covid-19 treat­ment. While that study al­so failed its pri­ma­ry end­point, re­searchers said the drug “re­duces the com­pos­ite rate of death or hos­pi­tal­iza­tion” in non-hos­pi­tal­ized pa­tients.

Out of 2,235 pa­tients in the colchicine group, 104 had been hos­pi­tal­ized or died; among 2,253 in the place­bo co­hort, 131 re­port­ed those events. That trans­lates to a 4.7% event rate ver­sus 5.8% on the pri­ma­ry end­point — or an odds ra­tio of 0.79 — with a p-val­ue of 0.08. Five pa­tients died in the colchicine arm, ver­sus nine in the place­bo group. On the sec­ondary end­point, 11 pa­tients tak­ing colchicine re­quired me­chan­i­cal ven­ti­la­tion while 21 who were giv­en place­bo did.

But if you look on­ly at the 4,159 pa­tients with PCR-con­firmed Covid-19, in­ves­ti­ga­tors wrote, the dif­fer­ence widens slight­ly to 4.6% ver­sus 6.0% and the 0.75 odds ra­tio be­comes sta­tis­ti­cal­ly sig­nif­i­cant (p=0.04).

Lan­dray com­ment­ed that it was a “trav­es­ty” that in­ves­ti­ga­tors in the tri­al had stopped en­roll­ment with on­ly 75% of pa­tients, adding that it re­sult­ed in in­con­clu­sive re­sults and un­cer­tain­ty. — Nicole De­Feud­is 

Italy blocks As­traZeneca vac­cine ship­ment meant for Aus­tralia

The As­traZeneca/Ox­ford vac­cine roll­out has run in­to yet an­oth­er speed bump.

As the British drug­mak­er prepped a vac­cine ship­ment for Aus­tralia of about 250,000 dos­es, Italy de­cid­ed to pre­vent the de­liv­ery from leav­ing its bor­ders, per a Fi­nan­cial Times re­port. It’s the first such in­ter­ven­tion in vac­cine ex­ports since the Eu­ro­pean Union in­tro­duced new rules gov­ern­ing such ship­ments out­side the bloc in late Jan­u­ary.

Per the FT re­port, the EU had the pow­er to ob­ject to Italy’s move and block their ef­fort, but did not do so. And ear­ly Fri­day morn­ing, France backed Italy’s plan to stop the ship­ment head­ed to Aus­tralia.

The con­tro­ver­sial ex­port plan was put in­to place by the EU in the wake of As­traZeneca say­ing it wouldn’t be able to pro­vide the amount of dos­es pledged in its con­tracts a lit­tle over a month ago. Their hope is to force com­pa­nies to dis­close ex­port plans, the FT cit­ed Eu­ro­pean of­fi­cials as say­ing, as the bloc seeks to re­assert con­trol of dos­es man­u­fac­tured in­side its bor­ders.

Sev­er­al coun­tries had been ex­empt­ed from the plan, al­low­ing for As­traZeneca shots to be able to flow to poor­er na­tions and those with­out their own pro­duc­tion ca­pa­bil­i­ties. EU of­fi­cials drew harsh crit­i­cism, how­ev­er, af­ter in­clud­ing the UK on the ex­emp­tion list de­spite leav­ing off oth­er in­dus­tri­al­ized na­tions like the US and Japan.

Fri­day’s de­vel­op­ments fol­low a rocky road for the As­traZeneca/Ox­ford vac­cine. Though Britain and the EU have au­tho­rized the shot for use, there has been slow up­take around the world as the drug­mak­er and the bloc fought pub­licly over the dos­es the com­pa­ny would pro­vide. And some peo­ple in Eu­ro­pean coun­tries are re­port­ed­ly shun­ning the vac­cine in fa­vor of mR­NA-based shots with high­er topline ef­fi­ca­cy lev­els. — Max Gel­man

Ger­many al­lows use of As­traZeneca’s vac­cine in se­niors — re­port

Days af­ter Cana­di­an of­fi­cials said As­traZeneca’s Covid-19 vac­cine should not be used on se­niors, Ger­many has re­versed its de­ci­sion to re­strict the jab from those 65 and old­er.

The Ger­man Health Min­istry’s Per­ma­nent Vac­cine Com­mis­sion OK’d the vac­cine for use on se­niors on Thurs­day, and an­nounced it would up­date guid­ance to in­cor­po­rate a new rec­om­men­da­tion that dos­es be spaced 12 weeks apart, BBC re­port­ed. 

Health Min­is­ter Jens Spahn called the de­ci­sion “good news for old­er peo­ple who are wait­ing for an in­jec­tion,” per BBC.

The move was based on new ev­i­dence that As­traZeneca and Ox­ford Uni­ver­si­ty pre­sent­ed last month, which they said proves their vac­cine is more ef­fec­tive when ad­min­is­tered over the course of 12 weeks. The new reg­i­men has al­ready been ap­proved by the UK.

In­ves­ti­ga­tors wrote in a Lancet study:

In our study, vac­cine ef­fi­ca­cy was high­er, af­ter the sec­ond dose, in those with a longer prime-boost in­ter­val, reach­ing 82.4% in those with a dos­ing in­ter­val of 12 weeks or more. Point es­ti­mates of ef­fi­ca­cy were low­er with short­er dos­ing in­ter­vals, though it should be not­ed that there is some un­cer­tain­ty as con­fi­dence in­ter­vals over­lap. High­er bind­ing and neu­tral­is­ing an­ti­body titres were ob­served in sera at the longer prime-boost in­ter­val, sug­gest­ing that, as­sum­ing there is a re­la­tion­ship be­tween the hu­moral im­mune re­sponse and ef­fi­ca­cy, these may be true find­ings and not arte­facts of the da­ta.

Back in Jan­u­ary, an ex­pert pan­el in Ger­many rec­om­mend­ed against giv­ing As­traZeneca’s vac­cine to those over the age of 65, cit­ing “in­suf­fi­cient da­ta avail­able to as­sess the vac­cine ef­fi­ca­cy.”

While a Cana­di­an pan­el of vac­cine ex­perts said ear­li­er this week that vac­cines from Pfiz­er/BioN­Tech and Mod­er­na are pre­ferred for those over 65, France al­so de­cid­ed Mon­day to al­low the vac­cine’s use in se­niors. — Nicole De­Feud­is 

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.