EndeavorRx screen (Akili Interactive)

FDA ap­proves first ther­a­peu­tic video game

Here’s a new one: The FDA has just ap­proved a pre­scrip­tion video game.

The brain­child of a cou­ple of cog­ni­tive sci­en­tists who built the pro­to­type tech­nol­o­gy over a decade ago, the video game is de­signed to help im­prove at­ten­tion func­tion in kids with AD­HD. It was de­vel­oped by Ak­ili In­ter­ac­tive, one of two ma­jor health tech video game com­pa­nies, and is called En­deav­or­Rx.

Doc­tors can pre­scribe it for kids ages 8 to 12 with AD­HD and a his­to­ry of at­ten­tion is­sues. A price has yet to be an­nounced, but an Ak­ili spokesper­son said in an email that they are work­ing to get cov­er­age from in­sur­ers and to “ex­pect pric­ing to be in the range of oth­er treat­ments like drugs and be­hav­ioral ther­a­py cur­rent­ly used in chil­dren with AD­HD.”

Adam Gaz­za­ley

The ap­proval is the cul­mi­na­tion of a years-long ef­fort to con­vince reg­u­la­tors that a video game could even be a pre­scrip­tion ther­a­py. Ak­ili was found­ed in 2011, with tech­nol­o­gy li­censed from Adam Gaz­za­ley’s lab at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, and got ear­ly back­ing from Pfiz­er, Shire and PureTech, among oth­ers. (Pear Ther­a­peu­tics, the oth­er ma­jor com­pa­ny in the space, was found­ed 2 years lat­er.) The idea was that, with the right al­go­rithms, a game could re­train neur­al net­works and help peo­ple with cer­tain cog­ni­tive dis­or­ders mul­ti­task, fo­cus, and process in­for­ma­tion.

Even as they test­ed the soft­ware in Alzheimer’s, AD­HD, de­pres­sion and autism, they en­coun­tered skep­ti­cism about the po­ten­tial im­pact. A 2013 meta-analy­sis an­a­lyzed 46 ex­per­i­ments on video games, and found they pro­duced “neg­li­gi­ble ef­fects for ex­ec­u­tive func­tion.” Ak­ili first asked for FDA ap­proval in mid-2018. For drugs, at least, a de­ci­sion gen­er­al­ly comes with­in 10 months.

En­deav­or­Rx was fi­nal­ly ap­proved based on 5 clin­i­cal tri­als, in­clud­ing a study pub­lished on April 1 in The Lancet Dig­i­tal Health that found that 25 min­utes of game play per day, 5 days a week, for 4 weeks “might be used to im­prove ob­jec­tive­ly mea­sured in at­ten­tion in pe­di­atric pa­tients with AD­HD.” It was cleared un­der the FDA’s De No­vo pro­gram for a new type of low- or mod­er­ate-risk de­vice.

Al­though on­ly ap­proved to­day, the game has ac­tu­al­ly been avail­able for over a month. In April, the FDA re­laxed reg­u­la­tions for low-risk men­tal health de­vices, and Ak­ili launched a site that al­lowed chil­dren to get the game for free for up to three months.

The game sends kids through land­scapes teem­ing with la­va or ice, or on un­der­wa­ter mis­sions, and re­wards them for com­plet­ing var­i­ous tasks.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.