FDA is­sues an­oth­er safe­ty alert re­lat­ed to fe­cal trans­plants, as da­ta sug­gest coro­n­avirus lingers in poop

Since 2013, the FDA has im­ple­ment­ed a pol­i­cy of “en­force­ment dis­cre­tion” re­gard­ing fe­cal mi­cro­bio­ta trans­plants (FMT) to treat re­frac­to­ry C. diff: While bio­phar­ma com­pa­nies work on de­vel­op­ing stan­dard­ized prod­ucts, physi­cians can con­duct FMT’s af­ter se­cur­ing rea­son­able con­sent from pa­tients. But since last sum­mer, a hand­ful of safe­ty is­sues have caused a stir in the field.

Ear­li­er this week, the FDA is­sued a safe­ty alert high­light­ing the risk of po­ten­tial trans­mis­sion of the new coro­n­avirus from fe­cal mat­ter de­rived from donors used in FMT, and said that ad­di­tion­al safe­ty mea­sures are nec­es­sary.

“Sev­er­al re­cent stud­ies have doc­u­ment­ed the pres­ence of SARS-CoV-2 ri­bonu­cle­ic acid (RNA) and/or SARS-CoV-2 virus (which caus­es Covid-19) in stool of in­fect­ed in­di­vid­u­als. This in­for­ma­tion sug­gests that SARS-CoV-2 may be trans­mit­ted by FMT, al­though the risk of such trans­mis­sion is un­known,” the reg­u­la­tor said in a state­ment.

Ear­li­er this month, an in­ter­na­tion­al pan­el of ex­perts in FMT stressed in an ar­ti­cle in The Lancet Gas­troen­terol­o­gy and He­pa­tol­ogy, that up­dat­ing (at least tem­porar­i­ly) the screen­ing of stool donors is im­per­a­tive — as the risk of trans­mit­ting SARS-CoV-2 by FMT might be high­er than that in oth­er tis­sue trans­plants. A 98-pa­tient study in Chi­na yield­ed da­ta that sug­gest­ed the pos­si­bil­i­ty of ex­tend­ed du­ra­tion of vi­ral shed­ding in fe­ces, for near­ly 5 weeks af­ter the pa­tients’ res­pi­ra­to­ry sam­ples test­ed neg­a­tive for SARS-CoV-2 RNA.

De­signed to re­plen­ish gut mi­crobes, FMT has shown high rates of ef­fi­ca­cy in the treat­ment of re­cur­rent C. dif­fi­cile, a stub­born in­fec­tion that has grown re­sis­tant to ex­ist­ing an­tibi­otics and kills more than 29,000 Amer­i­cans each year.

FMT re­quires a stool sam­ple to be screened, liq­ue­fied and de­liv­ered to the colon by nasal or rec­tal tube. Pa­tients must ei­ther find their own donor, ob­tain vi­able stool from a li­censed health care provider, or turn to a stool bank, such as Open­Bio­me. Few­er than 3% of the pop­u­la­tion qual­i­fy as healthy donors, ac­cord­ing to the Fe­cal Trans­plant Foun­da­tion.

On Mon­day, the FDA is­sued rec­om­men­da­tions to mit­i­gate the risk of se­ri­ous ad­verse events for any fe­cal ma­te­r­i­al that has been do­nat­ed since De­cem­ber 1, 2019 and is be­ing con­sid­ered for use in an FMT pro­ce­dure, in­clud­ing test­ing donors and donor stool for SARS-CoV-2 if fea­si­ble and de­vel­op­ing cri­te­ria to ex­clude of donors and donor stool based on screen­ing and test­ing.

Ear­li­er in March, the FDA is­sued a sep­a­rate safe­ty alert af­ter E. coli-taint­ed stool from the non-prof­it stool bank Open­Bio­me made six pa­tients sick, four of whom were hos­pi­tal­ized. Two oth­er FMT re­cip­i­ents whose trans­plants com­prised Open­Bio­me’s prod­uct al­so died. Last sum­mer, the death of an im­muno-com­pro­mised el­der­ly pa­tient in an FMT tri­al at the Mass­a­chu­setts Gen­er­al Hos­pi­tal — due to a stool do­na­tion that con­tained a rare type of E. coli bac­te­ria — sent shiv­ers across the field.

Er­ic Shaff Seres

“These safe­ty alerts point to the fact that donor screen­ing is…nec­es­sary but in­suf­fi­cient to min­i­mize the in­fec­tion risk for donor-de­rived mi­cro­bio­me, and fe­cal trans­plant prod­ucts,” said Er­ic Shaff, CEO of Seres Ther­a­peu­tics, in an in­ter­view.

A few years ago, the spec­tac­u­lar fail­ure of Seres Ther­a­peu­tics’ sem­i­nal Phase II tri­al test­ing its “crap­sule” — donor-de­rived processed fe­cal ma­te­r­i­al en­cap­su­lat­ed in a pill — de­railed the emerg­ing field.

Now, as Seres awaits the re­sults of a key study, the com­pa­ny was keen to point out in a state­ment that its man­u­fac­tur­ing process in­volves mul­ti­ple lay­ers of test­ing of sam­ples, in­clud­ing the use of ethanol, be­yond the ini­tial screen­ing of fe­cal mat­ter.

What these FDA alerts show is that with FMT, there will al­ways be an is­sue that must be chased, said Seres’ chief tech­nol­o­gy of­fi­cer John Aunins in an in­ter­view.

John Aunins Seres

“You didn’t test pre­vi­ous agents, or you use the test that wasn’t sen­si­tive enough or a pathogen emerges and you don’t have a test for it. So it’s, it’s just an in­her­ent sit­u­a­tion with that kind of a prod­uct.”

Seres’ analy­sis sug­gests that in the case of C. diff, for in­stance, the most ben­e­fit can be de­rived from bac­te­r­i­al spores, and Seres’ man­u­fac­tur­ing ap­pa­ra­tus iso­lates these spores from donor stool.

To be sure, ex­perts ac­knowl­edge that in the gut, it has still not re­al­ly been es­tab­lished what it means to be healthy. The in­ter­ac­tion be­tween the mi­crobes and the host hap­pens in many dif­fer­ent di­men­sions, on an anatom­i­cal lev­el as well as in terms of metabo­lites and im­munol­o­gy — mak­ing the de­ter­mi­na­tion rather com­plex.

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

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Robert Davis, Merck CEO

Mer­ck shares slide as re­sponse to its oral Covid an­tivi­ral plunges on lat­est up­date

After a second look, Merck says that its big breakthrough on the Covid front doesn’t look so good.

The pharma giant updated its data on its oral antiviral molnupiravir on Friday, and said that its drug reduced the rate of hospitalization and death by 30% — a sharp plunge from the 50% rate reported at the beginning of October during their interim readout.

And the news sparked a sharp retreat on Merck’s shares, which fell 4% ahead of the bell on Friday.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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