Akili Announces ENDEAVORTM Digital Attention Treatment is Now Available for Children with Attention Deficit Hyperactivity Disorder (ADHD) under FDA’s COVID-19 Enforcement Discretion Guidance

BOSTON–(BUSINESS WIRE)–#ADHD—Akili today announced that ENDEAVOR^TM (AKL-T01) is now available for use by children with attention deficit hyperactivity disorder (ADHD) and their families. Delivered through a captivating video game experience, ENDEAVOR is a digital treatment that has been shown in a rigorously designed and conducted clinical research program 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. Attention impairments are a component of ADHD in more than 85% of children diagnosed and can significantly impact daily functioning.

Akili is pursuing U.S. Food and Drug Administration (FDA) clearance of ENDEAVOR as a prescription treatment for use in pediatric ADHD. In parallel, the current release of ENDEAVOR is in response to new guidance from FDA recognizing the need for access to certain low-risk clinically-validated digital health devices for psychiatric conditions including ADHD during the COVID-19 pandemic.

“The current environment is hard for any child. Increased stress and upended schedules and routines have a direct impact on our cognition, increasing our distractibility and making it harder to stay focused and to be organized,” said Scott Kollins, Ph.D., professor of psychiatry, director of the ADHD Program at Duke University School of Medicine. “For children with attention issues associated with ADHD, their daily challenges are exacerbated and many of their support systems are no longer accessible.”

Akili is releasing ENDEAVOR to families with children diagnosed with ADHD and struggling with chronic attention issues. For a limited time, Akili is providing access to ENDEAVOR to those who qualify at no cost.

“At Akili, we’ve been steadfast in our commitment to build a future where effective medicine is not only easily accessible but also can treat patients in an entirely new and engaging way,” said Eddie Martucci, Ph.D., chief executive officer of Akili. “During this time of increased need, we’re proud to be able to immediately offer our new clinically validated digital medicine experience to the ADHD community.”

While often underrecognized in the face of more overt externalizing symptoms of ADHD, inattentiveness experienced by many children living with ADHD can be substantial.

“The impact of inattentiveness on functioning in children with ADHD is apparent to me on a daily basis in my practice. It affects making and keeping friends, completing tasks, building confidence and succeeding in school. In a clinical trial setting, I’ve seen ENDEAVOR have positive impacts on these areas, and my hope is that this intervention could play a valuable role as part of an integrated and comprehensive treatment approach for children with attentional challenges,” said Raun Melmed, M.D., behavioral pediatrician and director of Melmed Center, Scottsdale, Ariz. and author of a series of books on mindfulness for children including “Marvin’s Monster Diary: ADHD Attacks!”

ENDEAVOR is the centerpiece of the Endeavor Treatment System^TM care program, which includes ENDEAVOR, Akili Assist^TM personal support services, and the ADHD Insight^TM companion app, designed to help parents track and better understand changes in their child’s behavior over time. Easily accessible from home, ENDEAVOR is downloaded from the App Store by families on their mobile devices and does not require any additional equipment.

Driven by the core belief at Akili that effective medicine can also be fun and engaging, ENDEAVOR is delivered through an action video game experience. Using ENDEAVOR, patients navigate a character through different worlds while avoiding obstacles and collecting targets to unlock new worlds and receive awards. The captivating experience of ENDEAVOR is designed to drive engagement and compliance.

With neuroscience and technology as its foundation, ENDEAVOR is built on the Akili Selective Stimulus Management engine (SSME^TM) core technology, a proprietary technology designed for the targeted activation of specific neural systems in the brain to treat diseases with associated cognitive dysfunction. SSME presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function. The technology implements algorithms that adapt in both real-time and between treatment sessions to automatically adjust the difficulty level for a treatment experience that is personalized to the needs of 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.

Clinical Studies of ENDEAVOR

Akili has rigorously tested ENDEAVOR across five clinical trials, which included more than 600 children diagnosed with ADHD. The research program included three studies in ADHD (STARS-ADHD, STARS-Adjunct and ADHD-POC) and two pilot studies in ADHD with different comorbidities (Sensory Processing Disorder and Autism Spectrum Disorder). The pivotal STARS-ADHD study was a multi-center, randomized, blinded, controlled study in 348 children diagnosed with ADHD, and results were recently published in The Lancet Digital Health journal. In the pivotal study, ENDEAVOR showed a statistically significant improvement compared to an educational-style video game control (p=0.006) on a change in the Attention Performance Index (API) of the Test of Variables of Attention (TOVA®), a computerized test cleared by FDA to evaluate the effects of interventions in ADHD. In the STARS-Adjunct open-label study, statistically significant improvement was seen in the IRS (a parent-reported clinician-administered scale of ADHD impairments) from baseline to after 4-weeks of treatment in both children on stimulants and off any ADHD medication. No serious adverse events have been associated with ENDEAVOR in any study to date. Some study participants (9.3%) experienced non-serious treatment-related adverse events with ENDEAVOR, including frustration, headache, dizziness, emotional reaction, nausea or aggression.

Access and Use of ENDEAVOR

The current release of ENDEAVOR is enabled by new guidance from FDA in response to the COVID-19 public health emergency. ENDEAVOR is available today for qualified families with children diagnosed with ADHD and struggling with chronic attention issues and who are willing to commit to following the ENDEAVOR instructions for use. ENDEAVOR is currently available for use on iOS devices. To check if they are eligible, parents of children with ADHD can visit Akili’s enrollment site at GetEndeavor.com. Parents should contact a physician before their child begins using ENDEAVOR.

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, ENDEAVOR, is a digital treatment to address inattention in children with attention deficit hyperactivity disorder (ADHD). ENDEAVOR is currently available under FDA’s enforcement discretion policy for use during the COVID-19 pandemic; it has not yet received FDA clearance. 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.

Contacts

Julie DiCarlo, Akili

julie@akiliinteractive.com
617.306.5823