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.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.