PureTech Founded Entity Akili Releases New Gameplay Features in the First and Only FDA-Cleared Video Game Treatment for Children With ADHD

By: PureTech Health plc via Business Wire

July 22, 2021 at 08:09 AM EDT

New EndeavorRx^® features released as Akili begins to scale its commercial activities

PureTech Health plc (Nasdaq:PRTC, LSE:PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, today announced that its Founded Entity, Akili Interactive (“Akili”), introduced new gaming features and functionalities to its EndeavorRx^® treatment. The new gameplay features are being released as Akili begins its go-to market approach to bring EndeavorRx to families and healthcare professionals at scale.

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PureTech’s Founded Entity, Akili Interactive, introduced new gaming features and functionalities to its FDA-cleared EndeavorRx treatment for children with ADHD. The new gameplay features are being released as Akili begins to scale its commercial activities. (Graphic: Business Wire)

Akili leveraged its expertise in two disparate industries – medicine and gaming – to identify opportunities to enhance the EndeavorRx gameplay experience without changing Akili’s patented Selective Stimulus Management Engine (SSME™) core technology designed to improve attention function. The enhancements were based on the latest trends in video game development and informed by user insights collected across multiple forums, including playtesting, workshops, in-depth interviews with patients and caregivers, surveys, gameplay data and longitudinal research.

The full text of the announcement from Akili is as follows:

Akili Releases New Gameplay Features in the First and Only FDA-Cleared Video Game Treatment for Children With ADHD

Akili delivers on commitment to unparalleled patient experiences with continuous product enhancements

New EndeavorRx features released as Akili begins to scale its commercial activities

BOSTON, Mass. – July 22, 2021 – Akili Interactive (“Akili” or “Company”), maker of the first and only prescription video game treatment, today introduced new gaming features and functionalities to its EndeavorRx^® treatment following its U.S. Food and Drug Administration (FDA) clearance in June 2020. The new gameplay features are part of Akili’s commitment to continuous product iterations to create enjoyable, entertaining patient experiences and are being released as Akili begins its go-to market approach to bring EndeavorRx to families and healthcare professionals at scale. Leveraging insights from caregivers and patients, Akili game designers and engineers have created additional gameplay experiences that offer exciting new quests and increased optionality, including new personalized universes and character choices to enhance engagement in the prescription digital therapeutic. Enabled by the adaptive ability of digital therapeutics and the dynamic nature of video games, these enhancements evolve the gameplay experience for patients while preserving the regulated core technology of the product.

Because EndeavorRx is uniquely delivered through a video game, a number of gameplay components can be enhanced to drive user engagement and motivation. Akili leveraged its expertise in two disparate industries – medicine and gaming – to identify opportunities to enhance the EndeavorRx gameplay experience without changing Akili’s patented Selective Stimulus Management Engine (SSME™) core technology designed to improve attention function. The enhancements were based on the latest trends in video game development and informed by user insights collected across multiple forums, including playtesting, workshops, in-depth interviews with patients and caregivers, surveys, gameplay data and longitudinal research.

“Rapid product iteration is critical to creating amazing experiences for patients and delivering on the full promise of digital therapeutics,” said Carl Gottlieb, Senior Vice President of Engineering at Akili Interactive. “Since obtaining FDA clearance, we’ve been listening and learning, and are taking a dynamic patient-responsive approach to create an amazing experience -- from the product to the delivery process. Because EndeavorRx is uniquely delivered through a video game, we have nearly endless opportunities to enhance the product and evolve it based on user feedback and gaming trends to drive enjoyment and engagement.”

New features were added to EndeavorRx, with a primary focus on gameplay progress, increased choice and personalization. The enhancements provide patients with more strategic challenges and add complexity to both short-term and long-term goals to drive motivation. Patients now have more choices during gameplay, including selecting and unlocking new creatures and costumes, completing new quests, and building their own universes, which provide increased optionality and foster longer-term engagement and interest.

“My son began playing EndeavorRx last year, and these new features have personalized the game even further to his unique player level and capabilities,” said Kelcey Sihanourath, whose 12-year-old son has ADHD. “All of the interesting graphics and worlds he can visit keep him motivated and the gaming experience fresh and entertaining, despite it being an actual prescription treatment. For example, I remember he was saving up his rewards for one particular costume, and was so proud to show it to me once he had earned enough points. It has been such a rewarding experience to be able to give my son a treatment in the form of a video game he’s happy and excited about playing!”

EndeavorRx treatment was granted FDA clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomized, controlled study (STARS) published in The Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD. In March 2021, data published in Nature Digital Medicine from a multi-site open-label study (STARS Adjunct) evaluating the impact of EndeavorRx on symptoms and functional impairments in children with ADHD demonstrated statistically significant improvement in all predetermined endpoints of the study, which included parent and clinician ratings of children’s ADHD symptoms and related impairments in daily life.

To learn more or download a guide on how to talk to a child’s doctor about EndeavorRx, please visit EndeavorRx.com.

EndeavorRx^® Indication and Overview

EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA^®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication.

EndeavorRx is built on the Akili Selective Stimulus Management Engine (SSME™) core technology, a proprietary technology designed to target key attentional control systems in the brain. SSME technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient. This enables second by second monitoring of patient progress completing the treatment sessions, and continuously challenges each patient to an optimized level, encouraging patients to improve their performance. Driven by the core belief at Akili that effective medicine can also be fun and engaging, EndeavorRx is delivered through an action video game experience. The captivating experience of EndeavorRx is designed to drive engagement and compliance. To learn more about EndeavorRx, please visit EndeavorRx.com.

About Akili

Akili is combining scientific and clinical rigor with the ingenuity of the tech and entertainment industries to challenge the status quo of medicine. Akili is pioneering the development of digital treatments and care solutions to help people affected by cognitive impairments. Akili’s treatments are designed to directly activate the networks in the brain responsible for cognitive function and have been rigorously tested in extensive clinical studies, including prospective randomized, controlled trials. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s treatments are delivered through captivating action video game experiences. For more information, please visit AkiliInteractive.com.

Akili, EndeavorRx, and SSME, and any logo(s) for each, are trademarks or registered trademarks of Akili Interactive Labs, Inc. Other trademarks are trademarks or registered trademarks of their respective owners.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including inflammatory, fibrotic and immunological conditions, intractable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's Founded Entities, is comprised of 26 therapeutics and therapeutic candidates, including two that have received FDA clearance and European marketing authorization, as of the date of PureTech’s most recently filed Annual Report on Form 20-F. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company's unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements, including statements that relate to the Akili’s goals with respect to the EndeavorRx gameplay experience, the company's future prospects, development plans and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, our expectations regarding the EndeavorRx features and gameplay enhancements, and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.