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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”