Covid-19 roundup: Abi­vax pulls the plug on its an­ti-in­flam­ma­to­ry treat­ment; J&J says it could fall short on Q2 vac­cine sup­ply for EU — re­port

An­oth­er Covid-19 treat­ment is bit­ing the dust af­ter an in­de­pen­dent Da­ta Safe­ty and Mon­i­tor­ing Board flagged it for lack of ef­fi­ca­cy.

Paris-based Abi­vax shared last week that it’s slam­ming the brakes on its Phase IIb/III clin­i­cal tri­al for ABX464 in high-risk Covid pa­tients. The study, dubbed miR-AGE, had al­ready re­cruit­ed 500 pa­tients of the planned 1,034.

Re­searchers were test­ing the an­ti-in­flam­ma­to­ry to see if it could pre­vent se­vere dis­ease. But a planned in­ter­im analy­sis of da­ta from 306 pa­tients showed no dif­fer­ence be­tween the drug and a place­bo. ABX464 was well-tol­er­at­ed and safe, Abi­vax not­ed.

The re­sults came as a shock to some re­searchers, in­clud­ing Jorge Kalil, a pro­fes­sor at the Uni­ver­si­ty Hos­pi­tal Cen­ter in São Paulo and na­tion­al co­or­di­na­tor of the miR-AGE study in Brazil.

“As an im­mu­nol­o­gist, I am puz­zled by the out­come of the in­ter­im analy­sis, as ABX464 ad­dress­es both the vi­ral and in­flam­ma­to­ry as­pects of the dis­ease,” Kalil said in a state­ment. “How­ev­er, we rec­og­nize that Covid-19 is a nov­el, hy­per-acute and com­plex dis­ease that in­volves var­i­ous vi­ral and in­flam­ma­to­ry path­ways, plus the co­ag­u­la­tion sys­tem, which are still not ful­ly un­der­stood.”

While Abi­vax CEO Hart­mut Ehrlich called the find­ings “dis­ap­point­ing,” he em­pha­sized that ABX464 has shown pos­i­tive da­ta in ul­cer­a­tive col­i­tis, where it was al­ready be­ing test­ed be­fore en­ter­ing the Covid study.

ABX464 isn’t the on­ly po­ten­tial Covid-19 treat­ment can­di­date to come up short. Just last week, the UK’s RE­COV­ERY tri­al halt­ed 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.”

J&J says it could fall short on Q2 vac­cine sup­ply for EU re­port

The EU could soon be fac­ing more vac­cine dis­tri­b­u­tion woes, as John­son and John­son wor­ries it won’t be able to meet its Q2 quo­ta.

J&J told the EU that it was “un­der stress” to meet its goal of 55 mil­lion dos­es by the end of June, an un­named EU of­fi­cial told Reuters. The com­pa­ny cit­ed is­sues with the sup­ply of in­gre­di­ents and equip­ment, ac­cord­ing to the of­fi­cial.

The sin­gle-dose vac­cine has al­ready been au­tho­rized by the FDA, and is ex­pect­ed to get the OK for use in the EU on March 11. J&J is on the hook for 200 mil­lion dos­es to the bloc this year, and de­liv­er­ies are ex­pect­ed to start as ear­ly as April, Reuters re­port­ed.

Fail­ing to meet the Q2 goal could spell out a headache for the EU, which has al­ready been deal­ing with dis­tri­b­u­tion lags. Italy threat­ened to take le­gal ac­tion back in Jan­u­ary, al­leg­ing that de­liv­er­ies of the Pfiz­er/BioN­Tech vac­cine were un­ex­pect­ed­ly cut. Ger­many’s Ham­burg al­so re­port­ed re­ceiv­ing a small­er ship­ment. And last week, Italy and the EU blocked a 250,000-dose ship­ment of As­traZeneca’s vac­cine to Aus­tralia to pro­tect its own sup­ply.

Ten­sions rise be­tween EMA and Russ­ian vac­cine de­vel­op­er

Af­ter the head of the EMA’s man­age­ment board ad­vised EU coun­tries to hold off on au­tho­riz­ing Rus­sia’s Sput­nik V vac­cine, the shot’s de­vel­op­ers want an apol­o­gy.

“We de­mand a pub­lic apol­o­gy from EMA’s Christa Wirthumer-Hoche for her neg­a­tive com­ments on EU states di­rect­ly ap­prov­ing Sput­nik V,” a post from the of­fi­cial Sput­nik V Twit­ter ac­count reads. “Her com­ments raise se­ri­ous ques­tions about pos­si­ble po­lit­i­cal in­ter­fer­ence in the on­go­ing EMA re­view.”

Wirthumer-Hoche said dur­ing a talk show on Sun­day that the EU should wait to au­tho­rize the vac­cine while the EMA re­views its safe­ty and ef­fi­ca­cy, ac­cord­ing to a Reuters re­port.

While the vac­cine has been met with much skep­ti­cism, a Lancet study pub­lished last month sug­gests Sput­nik V has an ef­fi­ca­cy rate of 91.6%. The re­sults came from a 20,000-per­son Phase III tri­al, and ef­fi­ca­cy rate was based on the num­ber of Covid-19 cas­es tracked 21 days af­ter the first dose was ad­min­is­tered. Sput­nik V’s pro­tec­tion ap­plied to all age groups, in­clud­ing those old­er than 60, the Lancet re­sults said. No se­ri­ous ad­verse events re­lat­ed to the vac­cine were not­ed, though 45 pa­tients in the vac­cine group ex­pe­ri­enced se­ri­ous side ef­fects un­re­lat­ed to the vac­cine, ac­cord­ing to the Gama­leya Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy.

Rus­sia reg­is­tered the vac­cine back in Au­gust — and Pres­i­dent Vladimir Putin says his daugh­ter took it — well be­fore Phase III stud­ies were com­plet­ed. The move spurred much back­lash, in­clud­ing from the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions, which wrote a let­ter urg­ing Russ­ian health min­is­ter Mikhail Murashko not to give out an un­proven vac­cine.

“EMA did not al­low such state­ments about any oth­er vac­cine. Such com­ments are in­ap­pro­pri­ate and un­der­mine cred­i­bil­i­ty of EMA and its re­view process,” the Sput­nik V ac­count tweet­ed. “Vac­cines and EMA should be above and be­yond pol­i­tics.”

Pfiz­er/BioN­Tech vac­cine neu­tral­izes vari­ant spread­ing in Brazil — study

In a test to see how Pfiz­er and BioN­Tech’s vac­cine fares against new vari­ants emerg­ing around the world, the jab was able to neu­tral­ize the P.1 vari­ant, which was first de­tect­ed in Brazil, ac­cord­ing to a let­ter to the ed­i­tor of the New Eng­land Jour­nal of Med­i­cine. 

The jab al­so neu­tral­ized vari­ants first de­tect­ed in the UK (B.1.1.7-spike) and South Africa (B.1.351-spike), and two sub­sets of mu­ta­tions de­rived from B.1.351 lin­eage. But com­pared to an ear­ly iso­late of the virus, neu­tral­iza­tion of the South Africa vari­ant was weak­er by about two-thirds.

From the let­ter:

Our da­ta are al­so con­sis­tent with poor­er neu­tral­iza­tion of the virus with the full set of B.1.351- spike mu­ta­tions than virus with ei­ther sub­set of mu­ta­tions and sug­gest­ed that virus with mu­tant residues in the re­cep­tor-bind­ing site (K417N, E484K, and N501Y) is more poor­ly neu­tral­ized than virus with Δ242-244, which is lo­cat­ed in the N-ter­mi­nal do­main of the spike pro­tein.

Geo­met­ric mean neu­tral­iz­ing titers against the UK and Brazil vari­ants were “rough­ly equiv­a­lent” to those pro­duced against the ear­ly iso­late, while titers against the South African vari­ant were “ro­bust but low­er,” the au­thors from the Uni­ver­si­ty of Texas Med­ical Branch wrote.

Pri­or stud­ies have sug­gest­ed that Pfiz­er and BioN­Tech’s vac­cine can pro­tect against vari­ants spread­ing in the UK and South Africa, though may be less po­tent against the South Africa vari­ant. The com­pa­nies are test­ing boost­er op­tions, in­clud­ing a third dose of the cur­rent vac­cine and a new for­mu­la­tion that specif­i­cal­ly tar­gets the vari­ant.

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

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As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

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Cynthia Butitta (L) and Joe Jimenez

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Joe Wiley, Amryt CEO

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