Akili Collab to Study Long COVID-Related Brain Fog

7 April 2021

 PureTech Health plc

PureTech Founded Entity Akili Collaborates with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to Study Digital Therapeutic AKL-T01 as Potential Treatment for Patients with COVID Brain Fog

AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Akili Interactive (Akili) today announced collaborations with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as "COVID brain fog"). There are currently no approved treatments for cognitive impairments in COVID-19 survivors.

Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01's ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition. AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function. The organizations aim to begin clinical recruitment for the studies in the next month.

Since being named a global pandemic by the World Health Organization in March 2020, clinicians continue to learn about the vast ways in which COVID-19 manifests in patients. Evidence is mounting on long-term neurological and cognitive symptoms that can persist in some COVID-19 patients after initial diagnosis, even after the virus is no longer detected in the body. A study published in Neuropsychopharmacology led by Drs. Abhishek Jaywant and Faith Gunning at Weill Cornell Medicine and NewYork-Presbyterian found that difficulties in attention, multitasking, and processing speed were common in hospitalized patients recovering from COVID-19¹. Of the patients in their study, 81% exhibited some degree of cognitive impairment¹. Recent research also shows these cognitive impairments may persist post-hospitalization and commonly occur in "post-COVID long haulers" or "long COVID" patients. These impairments can have a significant impact on survivors' daily functioning and quality of life, impacting the ability of most COVID-19 long haulers to work for six months or more according to a recent study². For more information on COVID brain fog, click here.

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

Akili Collaborates with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to Study Digital Therapeutic AKL-T01 as Treatment for Patients with COVID Brain Fog

AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function

BOSTON - April 7, 2021 -  Akili Interactive ("Akili" or "Company"), today announced collaborations with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as "COVID brain fog"). There are currently no approved treatments for cognitive impairments in COVID-19 survivors.

Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01's ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition. AKL-T01 is the first and only digital therapeutic specifically designed to improve attention function. The organizations aim to begin clinical recruitment for the studies in the next month.

"As frontline healthcare workers continue to fight the immediate acute symptoms of COVID-19, certain longer-term consequences of the illness are beginning to emerge, including serious cognitive impairments," said Anil S. Jina, M.D., Chief Medical Officer at Akili. "With more than 100 million infections globally and counting, the potential impact of long-term cognitive impairments in even a subset of these patients is devastating. We look forward to working with leading researchers at Vanderbilt, Weill Cornell and NewYork-Presbyterian to understand and improve COVID-19-related cognitive deficits."

Since being named a global pandemic by the World Health Organization in March 2020, clinicians continue to learn about the vast ways in which COVID-19 manifests in patients. Evidence is mounting on long-term neurological and cognitive symptoms that can persist in some COVID-19 patients after initial diagnosis, even after the virus is no longer detected in the body.  A study published in Neuropsychopharmacology led by Drs. Abhishek Jaywant and Faith Gunning at Weill Cornell Medicine and NewYork-Presbyterian found that difficulties in attention, multitasking, and processing speed were common in hospitalized patients recovering from COVID-19¹. Of the patients in their study, 81% exhibited some degree of cognitive impairment¹. Recent research also shows these cognitive impairments may persist post-hospitalization and commonly occur in "post-COVID long haulers" or "long COVID" patients. These impairments can have a significant impact on survivors' daily functioning and quality of life, impacting the ability of most COVID-19 long haulers to work for six months or more according to a recent study². For more information on COVID brain fog, click here.

"Clinicians are seeing an increase in cognitive impairments among COVID-19 patients and though we don't yet know how long these difficulties last, we are concerned about how these cognitive difficulties may affect people in their daily lives," said Gunning Ph.D., Vice Chair of Research in the Department of Psychiatry, associate professor of psychology in psychiatry at Weill Cornell Medicine, and associate attending psychologist at NewYork-Presbyterian/Weill Cornell Medical Center, who is the study coordinator. "It's critical that we identify therapeutics to help the increasing number of people whose lives have been impacted by cognitive impairments associated with COVID-19."

"The chronic symptoms of COVID-19 long haulers represent a serious and growing public health concern that will linger long after the acute nature of COVID-19 has passed," said James Jackson, PsyD, Assistant Director of The ICU Recovery Center at Vanderbilt and lead psychologist for the Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center at the Vanderbilt University Medical Center. "We're excited by the potential of new therapeutics that target cognitive impairments to help COVID-19 survivors."

AKL-T01 is built on the Akili Selective Stimulus Management Engine (SSME^TM), a disease agnostic proprietary technology designed to treat impaired cognitive function, specifically attention control. Delivered through an action video game experience, the first-in-class 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. SSME has been evaluated as a potential treatment for cognitive impairments associated with a number of different disease areas and has been studied in more than 2600 patients across 30 clinical trials. AKL-T01, branded EndeavorRx^TM, is cleared for use by the U.S. Food and Drug Administration (FDA)³ and has received Conformité Européenne (CE) Mark certification in Europe for use in pediatric ADHD⁴. Product screenshots and b-roll are available here.

Study Designs

The Akili, Weill Cornell Medicine and NewYork-Presbyterian Hospital randomized, controlled study will evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18-89 who have exhibited a deficit in cognition. The study will take place over 10 weeks, with 6 weeks of treatment and 4 weeks of follow-up. Half of the study participants will receive the digital treatment and half will serve as a control group. The primary endpoint of the study is mean change in cognitive function, as assessed by a measure of attention and processing speed. Secondary endpoints include additional measures of cognitive functioning. The study will be conducted remotely in patients' homes, and patients in the control arm will have the option to receive the AKL-T01 intervention after the conclusion of their participation in the control condition.

The Akili and Vanderbilt randomized, controlled study will evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18 and older who have exhibited a deficit in cognition. The study will recruit from subjects who have completed the SARS-CoV-2 Household Transmission Study. Half of the study participants will receive the digital treatment for 4 weeks and half will serve as a control group. The primary endpoint of the study is mean change in cognitive function, as measured by CNS Vital Signs (composite score of cognitive function, especially attention and processing speed). Secondary endpoints include additional measures of cognitive functioning. The study will be conducted remotely in patients' homes.

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 has pioneered the development of video game-based digital medicine to improve cognitive function. Akili's flagship product is a prescription digital treatment to address inattention in children with attention deficit hyperactivity disorder (ADHD). Akili's patented technology serves as the foundation of its products and is designed to directly activate the networks in the brain responsible for cognitive function. 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 that drive engagement and compliance. For more information, please visit AkiliInteractive.com.

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About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, 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, as of the date of PureTech's most recently filed Registration Statement on Form 20-F, was comprised of 24 therapeutics and therapeutic candidates, including two that have received FDA clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product 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 company's future prospects, developments, 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 potential therapeutic benefits of Akili's AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19,  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.

¹ Jaywant et al. Neuropsychopharmacol. (2021).

² David et al. Preprint. (2020).  

³ EndeavorRx is an FDA-cleared medical device. It 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.

⁴ In June, 2020, EndeavorRx received Conformité Européenne (CE) Mark certification as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with ADHD.