A new study breathes life in­to an all-but-dead ap­proach to treat­ing se­vere Covid-19

Maybe Roche’s IL-6 drug works for Covid-19 af­ter all.

Actem­ra, the rheuma­toid arthri­tis drug, was wide­ly used by doc­tors ear­ly in the pan­dem­ic on the the­o­ry that it could douse the over­ac­tive im­mune re­sponse that leads to se­vere symp­toms in many pa­tients. But mul­ti­ple stud­ies in the spring and sum­mer ap­peared to find that nei­ther the Roche drug nor a sim­i­lar an­ti­body from Re­gen­eron and Sanofi had any ef­fect.

In Au­gust, BAR­DA qui­et­ly sig­naled they would stop fund­ing IL-6 blocks for Covid-19. To some, the drugs be­came a sym­bol for the need to study mol­e­cules in a con­trolled fash­ion be­fore pulling them off the shelf in a cri­sis.

But to­day, REMAP-CAP, a glob­al tri­al net­work that has been test­ing dif­fer­ent Covid-19 drugs in an adap­tive fash­ion at 200 sites on 19 coun­tries, an­nounced that Actem­ra had worked in their study. A da­ta safe­ty and mon­i­tor­ing board re­viewed da­ta from 303 pa­tients and de­ter­mined Actem­ra had a 99.75% chance of be­ing bet­ter for the sick­est Covid-19 pa­tients than giv­ing them no im­mune mod­u­la­tor at all.

It’s still not clear the de­gree to which Actem­ra helped pa­tients in the tri­al. The tri­al reached a com­pos­ite end­point that com­bined sur­vival and the length of time, and in­ves­ti­ga­tors don’t know yet how the re­sults broke down.

In­ves­ti­ga­tors said they are prepar­ing the da­ta for full re­lease and peer-re­viewed pub­li­ca­tion. The ma­jor­i­ty of pa­tients in the study were in the UK.

If the re­sults hold up, it would make Actem­ra one of the on­ly drugs to have proven ef­fec­tive in late-stage Covid-19 pa­tients, just as cas­es and hos­pi­tal­iza­tions are surg­ing across the globe. The oth­er is dex­am­etha­sone, a cheap steroid that has helped re­duce the virus’s fa­tal­i­ty rate across the globe.

Al­though US doc­tors now give block­ers for IL-6 and an­oth­er im­mune sig­nal­ing mol­e­cule, IL-23, less of­ten, pre­scrip­tions con­tin­ue, ac­cord­ing to the most re­cent avail­able da­ta from Ae­tion. As of the week of Sept. 14, 1.9% of US pa­tients re­ceived some of im­mune block­er.

While the study gives new life for one re­pur­posed Covid-19 drug, it al­so dug a nail in­to the cof­fin of an­oth­er.  REMAP-CAP an­nounced to­day that they would stop test­ing the HIV an­tivi­ral cock­tail lopinavir/ri­ton­avir af­ter it failed a fu­til­i­ty analy­sis.

The cock­tail first failed a tri­al on se­vere cas­es in March, but stud­ies have con­tin­ued on ear­li­er stage pa­tients. The UK Re­cov­ery tri­al is still test­ing it.

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

Pascal Soriot (Getty)

As­traZeneca CEO So­ri­ot plans new study to test that con­tro­ver­sial 90% ef­fi­ca­cy fig­ure, wait­ing for US da­ta be­fore go­ing to FDA

Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

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Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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