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.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.