Mark Smith, Finch CEO

FDA lifts hold on Finch’s mi­cro­bio­me crap­sule, as com­pa­ny looks to right ship

Finch Ther­a­peu­tics’ lead pro­gram may fly again.

The mi­cro­bio­me com­pa­ny an­nounced Thurs­day that the FDA lift­ed a two-month hold on clin­i­cal tri­als for its ex­per­i­men­tal treat­ment for re­cur­rent C. diff, a po­ten­tial­ly fa­tal bac­te­r­i­al in­fec­tion. Al­though the com­pa­ny still has to take sev­er­al steps be­fore it can re­sume its piv­otal study, the lift re­moves an un­usu­al pan­dem­ic-re­lat­ed hur­dle for Finch as the biotech looks to get its first ther­a­py over the fin­ish line and sta­bi­lize a pre­car­i­ous fi­nan­cial sit­u­a­tion.

Finch is one of sev­er­al com­pa­nies at­tempt­ing to de­vel­op treat­ments for C. diff and oth­er dis­eases by giv­ing pa­tients tablets — some­times jok­ing­ly or not-so-jok­ing­ly re­ferred to as crap­sules — con­tain­ing bac­te­ria strains ex­tract­ed from donor stool. In the­o­ry, the new strains will re­col­o­nize the pa­tients’ gut, cre­at­ing an en­vi­ron­ment where C. diff can’t take hold.

In a pan­dem­ic, though, the FDA feared that stool sam­ples might be able to trans­mit SARS-CoV-2 be­tween pa­tients. (Oth­er se­ri­ous in­fec­tions have been passed through fe­cal trans­plant, a close­ly re­lat­ed but dis­tinct pro­ce­dure.)

In March 2020, the agency pro­hib­it­ed Finch from dos­ing tri­al pa­tients with drug de­rived from any donor sam­ples tak­en af­ter Dec. 1, 2019, but Finch said they were able to con­tin­ue tri­als with sam­ples banked be­fore that date. Be­gin­ning in ear­ly 2021, the com­pa­ny says it was able to start get­ting new donors again, first be­cause its con­tract man­u­fac­tur­er em­ployed SARS-CoV-2 screen­ing meth­ods and then be­cause it bought out some of the man­u­fac­tur­er’s tech­nol­o­gy and em­ployed the same screen­ing meth­ods.

In March 2022, though, the com­pa­ny said the agency raised ques­tions about those pro­ce­dures and paused en­roll­ment in a Phase III tri­al. Finch now says those con­cerns have been re­solved af­ter “a re­view of in­for­ma­tion Finch pro­vid­ed re­lat­ed to its SARS-CoV-2 screen­ing pro­ce­dures and as­so­ci­at­ed in­formed con­sent lan­guage.”

The hold couldn’t come soon­er for Finch. Al­though the com­pa­ny showed some of the first pos­i­tive re­sults in a ran­dom­ized mi­cro­bio­me tri­al in 2020, it has come on hard times as the larg­er biotech mar­ket has tak­en a down­turn.

Ear­li­er this month, the com­pa­ny laid off 37 em­ploy­ees, or 20% of its work­force. Its stock $FNCH has fall­en 85% over the past year, from $14.04 to $2.10 at the clos­ing bell Thurs­day. It is up $2.91 per mar­ket on the news.

It al­so side­lined a pro­gram in he­pati­tis B to re­serve cash.

The com­pa­ny’s fu­ture will de­pend on the Phase III re­sults from the tri­al, al­though that won’t get off the ground just yet. Al­though Finch says the agency has lift­ed the hold, it hasn’t done every­thing the FDA wants.

The com­pa­ny still needs to “com­plete cer­tain man­u­fac­tur­ing ac­tiv­i­ties and qual­i­ty sys­tem up­dates re­lat­ed to the re­cent­ly re­solved clin­i­cal hold,” it said. It al­so needs to sub­mit to the FDA a “val­i­da­tion pack­age” for one of its “re­lease tests” and it needs to change the al­go­rithms used to mon­i­tor whether a pa­tient has a re­cur­rent C. diff in­fec­tion.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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FDA ap­proves Re­by­ota, Fer­ring's poop-based drug to fight C. diff in­fec­tion

The FDA approved Ferring Pharmaceuticals’ Rebyota drug on Wednesday, a poop-based drug implant that can prevent the recurrence of Clostridioides difficile infection.

While the use of fecal microbiota transplantation (FMT) — replenishing a patient’s gut with bacteria from healthy feces — has already been happening without an FDA-approved product, Rebyota is the first drug approved by the agency to fight the potentially deadly infection.