UP­DAT­ED — Covid-19 roundup: WHO all but con­firms virus not man-made; Neu­roRx, Re­lief say they don't know if IV treat­ment works

The WHO has been work­ing on trac­ing the ori­gins of the Covid-19 pan­dem­ic in re­cent weeks, send­ing a field team to Wuhan, Chi­na, to in­ves­ti­gate. And Tues­day morn­ing, they all but ruled out the pos­si­bil­i­ty that the virus was man-made.

Re­searchers with the or­ga­ni­za­tion said the nov­el coro­n­avirus stem­ming from the re­sult of a lab ac­ci­dent was “ex­treme­ly un­like­ly,” con­firm­ing what most health ex­perts had said since it first emerged in late 2019. The ev­i­dence con­tin­ues to point to­ward the virus spread­ing from an­i­mals to hu­mans.

“All the work that has been done on the virus and try­ing to iden­ti­fy its ori­gin con­tin­ue to point to­ward a nat­ur­al reser­voir,” lead sci­en­tist Pe­ter Ben Em­barek said at a news con­fer­ence, per a New York Times re­port.

In speak­ing with re­porters, Em­barek swat­ted down the lab ac­ci­dent the­o­ry that had been pro­mot­ed at times by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, among oth­ers. “It was very un­like­ly that any­thing could es­cape from such a place,” he said, not­ing the heavy safe­ty pro­to­cols.

The WHO mis­sion comes af­ter months of crit­i­cism that the or­ga­ni­za­tion has gone out of its way to de­fer to the Chi­nese gov­ern­ment in its as­sess­ments of the pan­dem­ic. Chi­na had been re­luc­tant to al­low the sci­en­tists in­to the coun­try but ul­ti­mate­ly ac­qui­esced last month, let­ting the group of 14 con­duct their in­ves­ti­ga­tion.

The coun­try al­so used Tues­day’s news con­fer­ence to con­tin­ue as­sert­ing that the virus first ap­peared else­where, a the­o­ry that many health ex­perts dis­miss. WHO sci­en­tists have said they will in­ves­ti­gate these claims while al­so call­ing for more re­search in­to an­i­mals sold at a mar­ket in Wuhan where some of the first cas­es were re­port­ed.

Ef­fi­ca­cy for se­vere Covid-19 treat­ment still TBD, Neu­roRx and Re­lief say

Neu­roRx and Re­lief Ther­a­peu­tics have teamed up on de­vel­op­ing in­haled and IV for­mu­la­tions of an ex­per­i­men­tal drug for se­vere Covid-19 cas­es, and on Tues­day re­vealed that the ju­ry is still out on whether or not the IV pro­gram works as in­tend­ed.

The pair said they are still work­ing to de­ter­mine whether or not the can­di­date, dubbed Zye­sa­mi, met the pri­ma­ry end­point of re­cov­ery from res­pi­ra­to­ry fail­ure with­in 28 days in a Phase IIb/III study. Pa­tients are be­ing fol­lowed through 60 days.

The pair al­so re­vealed key sec­ondary end­point da­ta, in­clud­ing that re­searchers did not see dif­fer­ences in sur­vival ben­e­fit af­ter four weeks. Neu­roRx and Re­lief ap­peared to blame that on over­all ICU care im­prov­ing, say­ing in a re­lease “With the im­prove­ment in sur­vival since the start of the pan­dem­ic, dif­fer­ences in sur­vival were not seen at day 28.”

In­vestors in Re­lief were ap­par­ent­ly not pleased, send­ing shares of the Swiss pen­ny stock down more than 30%.

138 pa­tients out of a to­tal of 203 sur­vived in that time­frame, with 91 of those tak­ing Zye­sa­mi and 47 on stan­dard of care. Pa­tients were ran­dom­ized in­to the drug arm at a 2-to-1 ra­tio.

The com­pa­nies at­tempt­ed to high­light a small pos­i­tive in an­oth­er sec­ondary end­point, though, not­ing that pa­tients who were treat­ed with Zye­sa­mi on top of the max­i­mal stan­dard of care ben­e­fit­ed over place­bo. They mea­sured this out­put us­ing time to dis­charge from the hos­pi­tal, say­ing that in six of eight evalu­able cas­es pa­tients saw a three-day me­di­an dif­fer­ence in hos­pi­tal stay.

But by the com­pa­nies’ own ad­mis­sion, that find­ing may not end up mean­ing any­thing.

“The sec­ondary end­point da­ta re­port­ed to­day should not cre­ate an ex­pec­ta­tion that the pri­ma­ry end­point will be met over­all or for any sub­group,” the com­pa­nies said.

End­points News sent out a re­quest for com­ment on the news, and re­ceived this in an emailed re­sponse from CEO Jonathan Javitt:

“The end­point da­ta we re­port­ed are sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly mean­ing­ful to doc­tors, pa­tients, and fam­i­lies. Re­duced hos­pi­tal stay has been a key ba­sis for reg­u­la­to­ry de­ter­mi­na­tions dur­ing the COVID pan­dem­ic and the re­duced hos­pi­tal stay seen in this pop­u­la­tion was shown in a pop­u­la­tion that lacks ef­fec­tive ther­a­pies. These da­ta are there­fore ma­te­r­i­al.”

The can­di­date it­self is a for­mu­la­tion of va­soac­tive in­testi­nal polypep­tide, which is known to be high­ly con­cen­trat­ed in the lungs. Though Tues­day’s re­sults come from the IV ver­sion of the pro­gram, the in­haled for­mu­la is cur­rent­ly in a Phase II/III study.

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

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Covid-19 roundup: CDC ad­vi­sors find like­ly link be­tween mR­NA vac­cines and rare cas­es of heart in­flam­ma­tion; NIH launch­es new vac­cine study in preg­nant vol­un­teers 

The FDA will update the fact sheets for the Pfizer/BioNTech and Moderna Covid-19 vaccines, after the CDC advisory group ACIP found that rare cases of heart inflammation in adolescents and young adults are likely linked to the shots, Reuters reported.

According to the CDC’s website, there have been more than a thousand reports of heart inflammation following mRNA vaccination since April. These cases are rare, according to the agency, given the hundreds of millions of doses administered. Most have been mild, and individuals often recover on their own or with minimal treatment, several public health figures said in a joint statement.