Big Phar­ma has skirt­ed long Covid, but a pipeline of small biotechs is test­ing treat­ments for lin­ger­ing symp­toms

Long Covid has been part­ly mys­te­ri­ous, due to the nascen­cy of SARS-CoV-2 as well as the vast­ness of lin­ger­ing symp­toms ex­pe­ri­enced by mil­lions of peo­ple world­wide fol­low­ing their ini­tial di­ag­noses.

That makes long Covid quite a wide um­brel­la term and has led to a large gap in R&D, as it ap­pears there’s a gen­er­al un­will­ing­ness of most bio­phar­mas to con­sid­er test­ing their drugs in this con­di­tion. For the most part, drug­mak­ers in­ter­est­ed in Covid-19 have most of their eggs in the pre­ven­tion and acute treat­ment bas­kets through vac­cines, mon­o­clon­al an­ti­bod­ies and an­tivi­rals.

Big Phar­ma and bio­phar­ma alike sure­ly are not done with test­ing new vac­cines and treat­ments for acute Covid-19. And some star­tups are just now emerg­ing to tack­le the pan­dem­ic, as ev­i­denced just this week by the launch of a new mAb biotech — fo­cused on a com­bo ther­a­py for im­muno­com­pro­mised pa­tients — led by Take­da’s for­mer vac­cines chief.

So drug­mak­ers, in­clud­ing the likes of Glax­o­SmithK­line, Vir Biotech­nol­o­gy, Hu­mani­gen, Pfiz­er and Roche, are in­ter­est­ed in the prospects of test­ing their drugs in pa­tients with long Covid, Reuters re­ports.

A Pfiz­er spokesper­son told End­points News in an emailed state­ment that the Big Phar­ma’s clin­i­cal tri­als aren’t cur­rent­ly eval­u­at­ing long Covid, but two stud­ies, EPIC-HR and EPIC-SR, “may pro­vide us with rel­e­vant da­ta to help in­form fu­ture stud­ies.” Those stud­ies of Paxlovid in­clude fol­low-up with pa­tients for six months, the spokesper­son not­ed.

For its part, Hu­mani­gen is test­ing its drug lenzilum­ab in hos­pi­tal­ized Covid-19 pa­tients but does “not have any plans to test long COVID,” the com­pa­ny told End­points in an emailed state­ment.

Re­gen­eron, which makes the emer­gency au­tho­rized pre­ven­ta­tive mAb known as RE­GEN-COV, told End­points that “long COVID is cer­tain­ly an area of in­ter­est for Re­gen­eron, but we have no ac­tive tri­als to in­ves­ti­gate this pop­u­la­tion at this time.”

Roche, mean­while, told End­points that the com­pa­ny rec­og­nizes “pa­tients’ need for Long COVID treat­ment. We are cur­rent­ly look­ing at what we can do to meet this need. It is sim­ply too ear­ly to share con­crete plans.”

Mil­lions of peo­ple glob­al­ly still ex­pe­ri­ence symp­toms months af­ter their ini­tial in­fec­tion, rang­ing from brain fog to gas­troin­testi­nal is­sues to oth­er res­pi­ra­to­ry dif­fi­cul­ties. But Big Phar­ma has seemed to fall to the way­side in cre­at­ing and test­ing treat­ments for this large pa­tient pop­u­la­tion.

So it’s main­ly been ju­nior drug de­vel­op­ers and biotechs with­out any ap­proved meds that have tried test­ing or plan to study their drugs in long Covid.

That list in­cludes Ax­cel­la Ther­a­peu­tics (with an in­ves­ti­ga­tion­al NASH med); NLS Phar­ma­ceu­tics; First Wave Bio­Phar­ma (for GI in­fec­tions as­so­ci­at­ed with long Covid); Am­pio Phar­ma­ceu­ti­cals; Re­gen­cell Bio­sciences; Or­gan­i­cell; Aim Im­munotech; Tonix Phar­ma­ceu­ti­cals (mid-stage study slat­ed first half of this year); Virios Ther­a­peu­tics; Pieris Phar­ma­ceu­ti­cals; NI­AID-col­lab­o­rat­ed Hu­ma­net­ics; and oth­ers, ac­cord­ing to an End­points re­view of SEC fil­ings, com­pa­ny state­ments and pipelines.

A bevy of com­pa­nies ditched their Covid-19 as­sets be­fore mak­ing it to mar­ket, whether for tri­al fail­ures, pipeline pri­or­i­ti­za­tion or claim­ing that there were enough treat­ments al­ready avail­able.

The same could hap­pen for bio­phar­mas work­ing on long Covid, and it’s al­ready hap­pened for Atea Phar­ma­ceu­ti­cals. Roche’s $350 mil­lion up­front cash bet on Atea blew up in Oc­to­ber 2021 when the biotech’s an­tivi­ral AT-527 flunked a mid-stage test. Roche called it quits on the pact a month lat­er.

Atea al­so ditched a six-month fol­low-on study of its an­tivi­ral AT-527 that was look­ing at the drug’s im­pact on long Covid in up to 1,000 pa­tients.

The cur­rent plan, an Atea spokesper­son told End­points, is to de­vel­op be­m­ni­fos­bu­vir (AT-527) as a “pre­ferred back­bone of com­bi­na­tion ther­a­py for COVID-19. At this time, our pro­gram does not in­clude plans for long-COVID.”

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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